Why Probiotic Formulation Identity Matters: Strains, CFU Counts and Clinical Evidence
Two probiotic products can share a brand family, overlap at species level, sit within 10 billion CFU of each other and still be different formulations. This UK guide explains what actually defines a probiotic formulation, why clinical evidence stays attached to the formulation that was studied, and uses the De Simone Formulation (sold in the UK as CDS22-formula) and Vivomixx neo® as a worked example of two different declared compositions.
A probiotic formulation is defined by its specific strains (identified by culture-collection codes, not species names alone), the proportions in which those strains are combined, the dose, and the human evidence generated with that exact combination. The World Gastroenterology Organisation's 2023 guideline states that probiotic benefits are most robustly linked to specific strains or strain combinations at the studied dose, and that strain designations, product names and trade names are not controlled by the scientific community. In the UK, probiotics such as CDS22-formula are food supplements under Food Standards Agency rules, not medicines, and this guide makes no claim that any product prevents, treats or cures disease. The De Simone Formulation is an eight-strain, 450 billion CFU formulation identified by codes DSM 24730-24737 / NCIMB 30435-30442; Vivomixx neo® is declared by its manufacturer as a nine-strain, 460 billion CFU formulation with different strain identifiers, in which two strains (IMC 502 and IMC 501) account for 82.6% of the total. A 2026 randomised, double-blind, placebo-controlled trial (Damianos et al., Mayo Clinic, n=24) identified its intervention as the eight-strain De Simone Formulation; as at 18 September 2026 no peer-reviewed human efficacy trial of the complete nine-strain Vivomixx neo® formulation was identified. None of this establishes that either product is safer, stronger or more effective than the other. CDS22-formula (12 sachets, £22.95 inc. 20% VAT) is available from Probiotic.co.uk with tracked next-day cold-chain delivery across the UK.
- UK consumers comparing probiotics that look similar on the shelf
- Pharmacists and dispensers asked whether two products are interchangeable
- Healthcare professionals and informed patients checking which formulation a study or guideline actually refers to
Probiotic formulation identity definition: the identity of a probiotic formulation is the complete set of specific strains it contains (each identified by an alphanumeric strain designation and, ideally, a culture-collection accession code), the proportions in which those strains are combined, the dose per serving, and the manufacturing process that keeps the live micro-organisms viable through shelf life.
De Simone Formulation definition: the De Simone Formulation is a specific eight-strain, high-concentration probiotic formulation developed by Professor Claudio De Simone, identified by culture-collection codes DSM 24730-24737 and NCIMB 30435-30442, and currently marketed as CDS22-formula.
No. The manufacturers' own published composition information describes CDS22-formula / the De Simone Formulation as an eight-strain, 450 billion CFU formulation identified by DSM and NCIMB codes, and Vivomixx neo® as a nine-strain, 460 billion CFU formulation with different declared strain identifiers and a different quantitative composition.[9][10] That makes them different formulations. It does not by itself establish that one is safer, stronger or more effective than the other, and no head-to-head human trial of the two was identified as at 18 September 2026. Both are food supplements in the UK, not medicines.
Vivomixx neo® should not be understood as the former eight-strain De Simone Formulation with a ninth strain added. The UK Vivomixx® website describes Vivomixx neo® as "a revised formulation" with nine strains.[15] Its manufacturer's published composition shows a broader change than one addition:[9]
- The nine declared strain identifiers (IMC 502, IMC 501, SP1, Bbr8, BLC1, LA1, 14D, SP38, SP4) share no public identifier with the De Simone Formulation's DSM 24730-24737 / NCIMB 30435-30442 set (manufacturer-declared; editorial comparison).
- Two strains, L. paracasei IMC 502 and L. rhamnosus IMC 501, account for 380 of 460 billion CFU: 82.6% of the sachet (editorial calculation from manufacturer figures).
- Total L. rhamnosus (IMC 501 + SP1) is 216 billion CFU, 47.0%. The De Simone Formulation contains no L. rhamnosus.
- Lactococcus lactis SP38 is present; it is not part of the De Simone Formulation.
- The L. helveticus strain of the De Simone Formulation (NCIMB 30440) is not listed.
- As at 18 September 2026, our dated search identified no peer-reviewed human efficacy trial of the finished nine-strain formulation (method and result below).
These facts establish that it is a different formulation with a separate evidence record. They do not establish that Vivomixx neo® is inferior, unsafe or ineffective.
- What defines a formulation: the specific strains, their proportions, the dose, and the manufacturing and stability process (WGO 2023; ISAPP 2014).
- How a strain is identified: genus + species (+ subspecies) + an alphanumeric strain designation, ideally with a culture-collection code such as DSM (DSMZ, Germany) or NCIMB (Aberdeen, UK).
- What CFU means: colony-forming units, a count of viable micro-organisms per dose. It describes quantity, not clinical effect.
- De Simone Formulation: 8 strains, 450 billion CFU per sachet, codes DSM 24730-24737 / NCIMB 30435-30442. Sold in the UK as CDS22-formula.
- Vivomixx neo®: 9 strains, 460 billion CFU per sachet, identifiers IMC 502, IMC 501, SP1, Bbr8, BLC1, LA1, 14D, SP38, SP4 (manufacturer's declared composition).
- CFU difference: 460 billion minus 450 billion = 10 billion, approximately 2.2%.
- Quantitative structure of Vivomixx neo®: IMC 502 (190 billion) + IMC 501 (190 billion) = 380 of 460 billion CFU, 82.6% of the sachet.
- Is a similar name proof of the same formulation? No. Trade names are not controlled by the scientific community (WGO 2023).
- UK regulatory status: both products are food supplements under FSA rules, not medicines. This guide makes no disease prevention, treatment or cure claim for either.
- UK VAT rate on food supplements: 20%.
- It does not claim that Vivomixx neo® is unsafe, ineffective or of lower quality. No published evidence supports such a statement and none is made here.
- It does not claim that CDS22-formula is clinically superior to Vivomixx neo®. No head-to-head human trial of the two formulations was identified as at 18 September 2026.
- It does not claim that a higher strain count or a higher CFU total is better, or worse. Neither number is a measure of clinical benefit on its own.
- It does not claim that CDS22-formula treats, prevents or cures any disease. It is a food supplement, not a medicine.
- It does not present Professor De Simone's published position as independent scientific consensus. Where his August 2026 materials are the source, they are named as such.
- It does not allege unlawful conduct by any company, distributor, pharmacy or healthcare professional.
What is well-supported: probiotic effects are strain-specific and formulation-specific; benefits are most robustly linked to specific strains or combinations at the studied dose (World Gastroenterology Organisation Global Guideline, Guarner et al., February 2023; ISAPP consensus, Hill et al., Nat Rev Gastroenterol Hepatol 2014, PMID 24912386).
What is not proven: that any two differently composed probiotic products are clinically equivalent, or that one is superior, without direct comparative human data. No head-to-head trial of the De Simone Formulation and Vivomixx neo® was identified as at 18 September 2026.
Most relevant human dose range: the 2026 Mayo Clinic trial of the De Simone Formulation used 900 billion bacteria three times daily for three weeks in 24 adults (Damianos et al., Aliment Pharmacol Ther 2026;64(6):748-757, PMID 42487516). The CDS22-formula UK label directs 1 to 2 sachets (450 to 900 billion CFU) per day for adults. A trial dose is not a label dose.
Key safety note: people who are immunocompromised, seriously ill, pregnant, breastfeeding or taking prescribed medicines should speak to a GP or pharmacist before taking any probiotic food supplement.
| Feature | Specification | Evidence Level |
|---|---|---|
| Unit of probiotic evidence | Specific strain or strain combination, at a specific dose, in a specific population and endpoint | Consensus (WGO 2023, ISAPP 2014) |
| Strain identification standard | Genus, species, subspecies, strain designation; deposit in a recognised culture collection (FAO/WHO) | Consensus (WGO 2023) |
| Species overlap = same formulation? | No. Two products can share species names and contain different strains | Consensus (WGO 2023) |
| Higher CFU = greater effect? | Not established as a general rule; CFU is a quantity measure | Not supported as a general rule |
| Evidence transfer between formulations | Not automatic; journals have issued corrections on this point (ECCO 2024; Cochrane 2020) | Documented |
| De Simone Formulation vs Vivomixx neo® | Different declared strain sets, identifiers and proportions (8 strains / 450 bn vs 9 strains / 460 bn) | Manufacturers' published compositions |
| Clinical equivalence or superiority of either | Not established either way | No head-to-head data identified |
| UK regulatory status | Food supplement under FSA rules; not a medicine; not MHRA-licensed; 20% VAT | Regulatory fact |
- What actually defines a probiotic formulation?
- Why strain identity matters in probiotic research
- Why clinical evidence cannot automatically be transferred between formulations
- The De Simone Formulation and CDS22-formula
- CDS22-formula and Vivomixx neo® are different formulations
- Why "nine strains instead of eight" does not tell the whole story
- What the guidelines and the newest human research say
- What evidence exists specifically for Vivomixx neo®?
- What to look for when comparing probiotics
- Frequently asked questions
What actually defines a probiotic formulation?
Walk down any pharmacy aisle in the UK and several probiotic boxes will look alike. Many list Lactobacillus and Bifidobacterium species, quote a CFU figure in the hundreds of billions, and carry brand names that sound related. None of those features, on its own, tells you whether two products are the same formulation.
The international consensus definition of a probiotic is "live microorganisms that, when administered in adequate amounts, confer a health benefit on the host" (FAO/WHO definition, reaffirmed by the ISAPP consensus panel, Hill et al., Nat Rev Gastroenterol Hepatol 2014, PMID 24912386).[1] The phrase "adequate amounts" and the word "microorganisms" both matter: the benefit belongs to particular organisms at a particular dose. Five components make up a formulation's identity.
Each organism is identified by genus, species, subspecies where applicable and an alphanumeric strain designation. A deposit code from a recognised culture collection (DSM, NCIMB, ATCC) anchors that designation to a physical reference sample.
Basis: WGO Global Guideline 2023, section 1.3Clinical evidence can relate to a specific combination of strains rather than to any one strain on its own. A changed strain set is a changed declared preparation; whether the clinical consequences are material requires product-specific evidence.
Basis: WGO 2023; ISAPP 2014Two products can contain overlapping species and still combine them in very different ratios. The proportions are part of the recipe, not an afterthought.
Basis: manufacturers' declared per-strain CFUCFU (colony-forming units) counts viable micro-organisms per dose. It is one characteristic of a formulation, not a measure of clinical effect, and higher CFU has not been shown to mean greater benefit as a general rule.
Basis: ISAPP 2014; WGO 2023Live organisms have to survive production, storage and shelf life. The process that keeps them viable is part of what makes one product that product.
Basis: WGO 2023 (viability to end of shelf life)Genus, species and strain: the hierarchy that matters
The World Gastroenterology Organisation's 2023 Global Guideline (Guarner, Sanders, Szajewska et al.) sets out the nomenclature plainly: a probiotic strain is identified by the genus, species, subspecies if applicable, and an alphanumeric designation that identifies a specific strain.[2] The guideline adds that, while genus and species names follow an agreed scientific nomenclature, strain designations, product names and trade names are not controlled by the scientific community.
| Level | What it identifies | Example | Is it enough to identify a probiotic? |
|---|---|---|---|
| Genus | A broad biological group of related bacteria | Lactobacillus, Bifidobacterium, Streptococcus | No |
| Species | A narrower group within the genus | Lactobacillus acidophilus, Bifidobacterium breve | No. Different strains of the same species can behave differently |
| Strain designation | A specific micro-organism within the species | L. acidophilus LA1; L. paracasei IMC 502 | Closer, but the designation is assigned by the manufacturer |
| Culture-collection code | The strain deposited in a recognised repository, with a stable public accession number | L. acidophilus DSM 24735 / NCIMB 30442 | Yes, for identifying the reference strain |
In 2020 the genus Lactobacillus was restructured and 23 new genera were defined, which is why the same organism may appear as Lactobacillus paracasei on one label and Lacticaseibacillus paracasei on another.[2] A change of scientific name does not create a new strain. A change of strain does.
A DSM or NCIMB code identifies the reference strain held by a culture collection. It does not, by itself, state that a finished product was manufactured from the physical sample held by that collection, and it does not by itself establish that two products carrying the same code are identical in every respect. It is the most stable public identifier available to a consumer, which is why this guide uses it, but it is an identifier, not a certificate of equivalence.
Why strain identity matters in probiotic research
"Contains Lactobacillus" and "contains Lactobacillus acidophilus NCIMB 30442" are two very different statements. The first names a genus that includes hundreds of species and countless strains. The second names one specific organism that can be obtained from a repository, sequenced and studied.
The WGO guideline states that the most robust approach links a benefit to specific strains or strain combinations at the effective dose, and that manufacturers should deposit their strains in an internationally recognised culture collection in line with FAO/WHO guidance.[2] The same document's clinical tables list interventions by strain or defined combination, not by species and not by brand.
The practical consequence for a UK shopper is simple. When a label lists species names without strain designations, you cannot tell which organism you are buying or whether it is the one that was studied. When it lists strain designations with recognised accessions, you are in a much stronger position to check whether a named strain matches the intervention described in a study.
Why clinical evidence cannot automatically be transferred between formulations
This is the central principle of the guide, and it is worth stating in one line: evidence follows the formulation. A clinical trial tests a defined intervention, at a defined dose, in a defined population, against a defined endpoint. Its result belongs to that intervention.
If Product A is studied in a trial, it does not follow that Product B carries the same evidence because some species overlap, the CFU total is similar, the brand name is related, or the number of strains is close. Each of those similarities is a description of packaging or labelling. None of them is a description of what happened in the trial.
How journals have handled this in practice
Scientific bodies have had to correct the record on exactly this point. The European Crohn's and Colitis Organisation published a correction in the Journal of Crohn's and Colitis (2023;17(1):149, PMID 35971821), amended on 2 January 2024, stating that until 2016 the De Simone Formulation was sold as VSL#3®, that after 2016 the VSL#3® product no longer contains the De Simone Formulation, and that the VSL#3® references in the 2017 ECCO Guidelines exclusively endorse the De Simone Formulation supported by the scientific evidence.[4]
The Cochrane Collaboration made a similar amendment on 4 May 2020 to its review of probiotics for maintenance of remission in ulcerative colitis (CD007443), noting that three included studies had assessed a formulation now known by the generic name De Simone Formulation, and that to the authors' knowledge no randomised trials had assessed the product currently sold as VSL#3® in that population.[6]
Both corrections are about attribution, not about any product's quality. They exist because a brand name had continued while the formulation behind it had changed, and readers of the literature needed to know which formulation the cited studies had actually tested. The same logic applies in the other direction, and to every probiotic: a product that shares a brand family, a species list or a CFU figure with a studied formulation does not inherit that formulation's evidence.
A change in the set of strains, or in their proportions, produces a different preparation, and the evidence base has to follow the preparation actually studied. This applies to the De Simone Formulation as much as to any other product: if its composition were ever changed, the older studies would no longer be studies of the new version.
The De Simone Formulation and CDS22-formula
The De Simone Formulation is a specific eight-strain, high-concentration probiotic formulation developed by Professor Claudio De Simone. In the published literature and in journal corrections it is referred to by that generic name rather than by any brand, precisely because the brands attached to it have changed over time.[4][6]
Historical product names, and why they matter for reading the literature
According to the ECCO correction, the formulation was sold as VSL#3® until 2016, and the VSL#3® product no longer contains it after that date.[4] The Cochrane amendment of May 2020 recorded that the formulation was at that time available under the brand names Visbiome® in the USA and Vivomixx® in the EU.[6] Clinical trial registrations from that period describe Vivomixx® as 450 billion cells of eight strains with the DSM 24730 to 24737 designations; the UCLH protocol registered as NCT03369431 is one example.[12] Today the formulation is marketed as CDS22-formula.
Those names are listed here for one reason only: so that a reader who finds "VSL#3®" in a 2010 paper or "Vivomixx®" in a 2018 trial registration can work out which formulation was studied. They should not be read as a statement that every product carrying one of those brand names today contains the De Simone Formulation. Whether a current product does is a question of its current declared composition, and the only reliable way to answer it is to compare strain identifiers and per-strain quantities, not names. The separate guides on the De Simone Formulation's timeline and strains and on what happened to the Vivomixx® 450 product in the UK cover that history in more detail.
CDS22-formula: the eight strains as declared on the UK label
CDS22-formula is a food supplement manufactured by EOS2021 S.r.l. The manufacturer states that it contains the De Simone Formulation; that is a manufacturer statement, not an independent finding, and no clinical trial has been published under the CDS22-formula product name. What can be checked independently is the label. Each 450 billion CFU sachet lists eight strains by NCIMB code with a per-strain quantity.[10]
| Strain (current name) | NCIMB code (UK label) | CFU per 450 bn sachet | Share of sachet |
|---|---|---|---|
| Streptococcus thermophilus | NCIMB 30438 | 226 billion | 50.2% |
| Lactobacillus acidophilus | NCIMB 30442 | 38 billion | 8.4% |
| Lactobacillus plantarum | NCIMB 30437 | 38 billion | 8.4% |
| Lactobacillus paracasei | NCIMB 30439 | 38 billion | 8.4% |
| Lactobacillus helveticus | NCIMB 30440 | 38 billion | 8.4% |
| Bifidobacterium breve | NCIMB 30441 | 24 billion | 5.3% |
| Bifidobacterium animalis subsp. lactis | NCIMB 30435 | 24 billion | 5.3% |
| Bifidobacterium animalis subsp. lactis | NCIMB 30436 | 24 billion | 5.3% |
| Total | 8 strains, NCIMB 30435-30442 | 450 billion | 100% |
Technical appendix: DSM to NCIMB cross-reference and historical species names
The manufacturer's composition information pairs each NCIMB code with a historical DSM (DSMZ, Germany) accession, and records two taxonomic reclassifications: the strains historically named Bifidobacterium longum (DSM 24736) and Bifidobacterium infantis (DSM 24737) are now classified as B. animalis subsp. lactis, and the strain historically named Lactobacillus delbrueckii subsp. bulgaricus (DSM 24734) is now classified as L. helveticus.[11] A taxonomic reclassification renames an organism; it does not create a new strain.
| Historical name and DSM code | Current NCIMB code |
|---|---|
| Streptococcus thermophilus DSM 24731 | NCIMB 30438 |
| Bifidobacterium breve DSM 24732 | NCIMB 30441 |
| Bifidobacterium longum DSM 24736 (now B. animalis subsp. lactis) | NCIMB 30435 |
| Bifidobacterium infantis DSM 24737 (now B. animalis subsp. lactis) | NCIMB 30436 |
| Lactobacillus acidophilus DSM 24735 | NCIMB 30442 |
| Lactobacillus plantarum DSM 24730 | NCIMB 30437 |
| Lactobacillus paracasei DSM 24733 | NCIMB 30439 |
| Lactobacillus delbrueckii subsp. bulgaricus DSM 24734 (now L. helveticus) | NCIMB 30440 |
What is Vivomixx neo®, and what changed from the De Simone Formulation?
Vivomixx neo® is a probiotic food supplement marketed by Mendes S.A. of Lugano, Switzerland and distributed in the UK by Gastropharm Ltd. Its official product information describes it as a nine-strain formulation providing 460 billion live bacteria per sachet, with a 115 billion capsule format also listed.[9] The UK Vivomixx® website describes it as "a revised formulation" containing nine strains.[15] It is refrigerated (2 to 8°C) and, per the manufacturer, free from gluten, lactose, soy allergens and milk proteins.
The manufacturer's published composition assigns the following quantities to the nine strains per 460 billion sachet (manufacturer-declared figures; percentages are editorial calculations).[9] The identifiers are the manufacturer's own designations (IMC, SP, Bbr, BLC, LA and 14D). On the official product pages accessed on 18 September 2026 (neo.vivomixx.eu and vivomixx.co.uk), no DSMZ or NCIMB accession codes were displayed for them.
| Strain (as declared) | Identifier | CFU per 460 bn sachet | Share of sachet |
|---|---|---|---|
| Lacticaseibacillus paracasei | IMC 502 | 190 billion | 41.3% |
| Lacticaseibacillus rhamnosus | IMC 501 | 190 billion | 41.3% |
| Lacticaseibacillus rhamnosus | SP1 | 26 billion | 5.7% |
| Bifidobacterium breve | Bbr8 | 9 billion | 2.0% |
| Bifidobacterium animalis subsp. lactis | BLC1 | 9 billion | 2.0% |
| Lactobacillus acidophilus | LA1 | 9 billion | 2.0% |
| Lactiplantibacillus plantarum | 14D | 9 billion | 2.0% |
| Lactococcus lactis | SP38 | 9 billion | 2.0% |
| Streptococcus thermophilus | SP4 | 9 billion | 2.0% |
| Total | 9 strains | 460 billion | 100% |
Vivomixx neo® is sold in the UK as a food supplement, and this guide makes no statement about its safety, quality or effect. What the declared composition establishes is set out in the box near the top of this guide and in the comparison table below.
CDS22-formula and Vivomixx neo® are different formulations
Placing the two declared compositions side by side shows the differences at every level that defines a formulation: the set of strains, the identifiers, the proportions and the evidence base. Every row below is taken from the manufacturers' own published information or from the cited literature; percentages are editorial calculations from the declared per-strain figures, and "not established" means no direct evidence was identified.[9][10]
| Characteristic | CDS22-formula / De Simone Formulation | Vivomixx neo® |
|---|---|---|
| Number of strains | 8 | 9 |
| Total CFU per sachet | 450 billion | 460 billion (+10 billion, approx. 2.2%) |
| Declared strain identifiers | DSM 24730-24737 paired with NCIMB 30435-30442 (culture-collection accessions) | IMC 502, IMC 501, SP1, Bbr8, BLC1, LA1, 14D, SP38, SP4 (manufacturer designations) |
| Do any identifiers match? | No public identifier is shared between the two declared compositions. Different identifiers alone do not prove genetic non-identity; identity cannot be assumed without authenticated strain mapping or genomic evidence, and we did not identify any such published source in the sources searched on 18 September 2026. | |
| L. rhamnosus | Not part of the formulation | Two strains (IMC 501, SP1), 216 billion CFU combined (47.0%) |
| L. helveticus | Present (NCIMB 30440, historically L. delbrueckii subsp. bulgaricus) | Not listed |
| Lactococcus lactis | Not part of the formulation | Present (SP38) |
| Largest single strain | S. thermophilus NCIMB 30438, 226 billion (50.2%) | L. paracasei IMC 502 and L. rhamnosus IMC 501, 190 billion each (41.3% each) |
| Two largest strains combined | 264 billion (58.7%) | 380 billion (82.6%) |
| Human evidence | Published human trials of the De Simone Formulation exist; the AGA 2024 pouchitis guideline and the ECCO correction identify the formulation by name (see below) | To be assessed on product-specific evidence for the finished nine-strain formulation; see the dedicated section below |
| UK regulatory status | Food supplement (FSA); not a medicine | Food supplement (FSA); not a medicine |
The conclusion the table supports is narrow and factual: these are two different declared compositions. It does not support any ranking between them. A separate UK comparison guide to CDS22-formula and Vivomixx neo® sets out the two strain lists side by side in more detail.
Why "nine strains instead of eight" does not tell the whole story
A strain count is a description of what is in a product. It says nothing about how the product is put together. Vivomixx neo®'s declared composition illustrates the gap between the two.
According to the manufacturer's published composition, L. paracasei IMC 502 contributes 190 billion CFU and L. rhamnosus IMC 501 contributes 190 billion CFU. Together that is 380 billion of the 460 billion CFU in the sachet, or 82.6%.[9] The remaining seven strains share the other 80 billion, with six of them at 9 billion each. Neither IMC 502 nor IMC 501 is part of the De Simone Formulation.
The De Simone Formulation's declared structure is different: its largest strain, S. thermophilus NCIMB 30438, is 226 billion of 450 billion (50.2%), and the two largest strains together are 58.7% of the sachet.[10] These are simply different quantitative shapes. An uneven composition is not inherently better or worse than a more even one; the point is only that "nine strains rather than eight" does not describe either shape, and that Vivomixx neo® is not the eight-strain formulation with one strain added.
Does 460 billion CFU mean more than 450 billion CFU?
Arithmetically, yes: 460 billion is 10 billion more than 450 billion, a difference of approximately 2.2% (10 ÷ 450 = 0.0222). Clinically, that number says nothing on its own.
CFU describes the quantity of viable micro-organisms in a dose. The ISAPP consensus and the WGO guideline both frame benefit in terms of specific strains at the dose shown to be effective, and neither treats a higher CFU total as evidence of a greater effect.[1][2] Which organisms make up the count matters more than the count. Our separate guide on high-strength probiotics in the UK covers what CFU does and does not tell you in more depth.
Two cautions cut both ways. There is no published evidence that the additional 10 billion CFU in Vivomixx neo® produces a greater effect. There is equally no basis for saying it has no biological effect. The honest statement is that a 2.2% difference in total count, between two products with different strains, is not a comparison of effect at all.
The 2026 Mayo Clinic trial of the De Simone Formulation administered 900 billion bacteria three times daily, 2,700 billion per day, for three weeks.[5] The CDS22-formula label directs adults to 1 to 2 sachets per day (450 to 900 billion CFU). A retail serving should never be assumed to equal the dose used in a cited trial, for any probiotic product.
What the guidelines and the newest human research say
Three documents show how the scientific and clinical community identifies the De Simone Formulation as a specific studied intervention. They are cited here for what they say about attribution. None of them is a treatment recommendation from this page, and CDS22-formula is not offered for the prevention or treatment of any condition.
AGA 2024: a formulation-specific guideline statement
The American Gastroenterological Association's 2024 Clinical Practice Guideline on the Management of Pouchitis and Inflammatory Pouch Disorders (Barnes et al., Gastroenterology 2024;166(1):59-85, PMID 38128971) conditionally suggests probiotics to prevent recurrence in patients with recurrent pouchitis that responds to antibiotics, and states that the De Simone Formulation was the probiotic used in the prevention trials, with the evidence limited to that formulation and that patient group.[3] The guideline names a formulation, not a brand and not a retail product. What the guideline does and does not say is set out in our UK guide to the AGA pouchitis guideline.
ECCO: attribution corrected, twice
As described above, ECCO's correction, amended on 2 January 2024, ties the VSL#3® references in its 2017 guidelines exclusively to the De Simone Formulation.[4] It is an evidence-attribution statement. It is not an endorsement of any current retail product, including CDS22-formula, and it says nothing about Vivomixx neo®.
2026: a randomised trial that names the eight-strain formulation
In July 2026, Damianos, Camilleri and colleagues at Mayo Clinic published a randomised, double-blind, placebo-controlled trial in Alimentary Pharmacology & Therapeutics (2026;64(6):748-757, PMID 42487516, NCT06609148). The intervention is described in the paper as the De Simone Formulation eight-strain probiotic, given as 900 billion bacteria three times daily for three weeks to 24 adults with a history of bile acid malabsorption.[5] The authors report that the probiotic improved the faecal bile acid profile, microbiome and metabolomic parameters relative to placebo, and call for larger and longer studies.
The study is included here for one reason: it shows a research group in 2026 identifying and testing a defined eight-strain formulation. It is not included to imply that any other product is ineffective, and its findings are not consumer health claims for CDS22-formula.
Damianos et al. 2026 (Mayo Clinic): the De Simone Formulation identified as the intervention
24 adults with a history of bile acid malabsorption were randomised to three weeks of the eight-strain De Simone Formulation (900 billion bacteria three times daily) or maltose placebo. The paper reports improvements in faecal primary bile acid profile, microbiome and metabolomic parameters. Small sample and short duration; the authors state that larger, longer studies are required. The trial identifies the formulation by name and strain codes rather than by brand.
Damianos JA, Matar A, Carlson P, et al. Aliment Pharmacol Ther. 2026;64(6):748-757. PMID 42487516. PMC13511384. DOI 10.1111/apt.70876.
EFSA 2015: the two-strain SYNBIO® combination assessed on its own
The EFSA NDA Panel evaluated SYNBIO®, the combination of L. rhamnosus IMC 501 and L. paracasei IMC 502 (the two strains that make up 82.6% of Vivomixx neo®), for a proposed health claim on maintenance of normal defecation. It concluded that a cause and effect relationship had not been established, noting that the three human intervention studies submitted used bowel-habit assessment tools whose validity had not been demonstrated. This opinion concerns those two strains and that claim only. It did not assess the complete nine-strain Vivomixx neo® product and is not a safety or efficacy judgement on it.
EFSA NDA Panel. EFSA Journal. 2015;13(5):4095. DOI 10.2903/j.efsa.2015.4095.
NCT07380009 (University of Thessaly): a registered study of Vivomixx neo® 460
A randomised, open-label study of Vivomixx neo® 460 in adults receiving antibiotic therapy, registered in January 2026 and recorded as completed on 30 May 2026. Its registered title and primary purpose concern acceptability of, and adherence to, different dosing regimens. It is a study of the finished nine-strain product, which matters for attribution; its endpoints are not clinical efficacy endpoints, and no peer-reviewed publication of results was identified as at 18 September 2026.
ClinicalTrials.gov NCT07380009. University of Thessaly. Status: completed (verified January 2026).
What the evidence record does not contain
No head-to-head human trial of the De Simone Formulation against Vivomixx neo® was identified. No clinical trial has been published under the CDS22-formula product name; the link between CDS22-formula and the De Simone Formulation rests on the manufacturer's statement and the label codes. The 2026 Mayo Clinic trial is small (n=24) and short (three weeks). Older De Simone Formulation trials were conducted under earlier brand names and must be read with the ECCO and Cochrane corrections in mind. None of this supports a claim of equivalence or superiority in either direction.
How the formulation's identity has been documented over time
The De Simone Formulation is sold as VSL#3®. After 2016, per the ECCO correction, the VSL#3® product no longer contains it.[4] European trial registrations of the period describe Vivomixx® as eight strains, 450 billion, DSM 24730-24737.[12]
Cochrane (4 May 2020) and ECCO (correction published 2022, amended 2 January 2024) clarify that the cited studies relate to the De Simone Formulation, not to the later product sold under the same historical brand.[6][4] In January 2024 the AGA pouchitis guideline names the De Simone Formulation as the probiotic used in the prevention trials.[3]
Mendes S.A. markets Vivomixx neo® as a nine-strain, 460 billion CFU product with its own strain identifiers.[9] A registered acceptability and adherence study of Vivomixx neo® 460 completes on 30 May 2026.[8]
Damianos et al. publish a randomised, double-blind, placebo-controlled trial that identifies its intervention as the eight-strain De Simone Formulation.[5]
What evidence exists specifically for Vivomixx neo®?
This is the section where wording matters most, so it is stated precisely, and the method is published so that anyone can repeat it. In the source review conducted for Professor De Simone's August 2026 materials, no peer-reviewed human trial of the complete nine-strain Vivomixx neo® formulation was identified as of 12 August 2026. Probiotic.co.uk did not rely on that review; it ran its own search.
Sources searched: PubMed and ClinicalTrials.gov records (retrieved via web search restricted to those records), Mendes S.A.'s official Vivomixx neo® product pages (neo.vivomixx.eu) and the UK Vivomixx® website (vivomixx.co.uk).
Terms used: "Vivomixx neo"; "Vivomixx neo 460"; "Vivomixx neo" with "randomised", "clinical trial" and "nine-strain"; the nine declared strain identifiers in combination.
Included: peer-reviewed human efficacy studies of the complete nine-strain, 460 billion CFU formulation, and registered studies of that finished product.
Excluded: studies of individual strains, of the two-strain SYNBIO® subset, of earlier eight-strain Vivomixx® products, of other brands, and animal or in-vitro work. Registered but unpublished studies are reported separately.
Result: one registered study of the finished product (NCT07380009, acceptability and adherence, completed 30 May 2026); no peer-reviewed efficacy publication for the finished nine-strain formulation in the sources searched. This is not proof that no such study exists. This section is scheduled for re-review in December 2026 and will be updated if product-specific evidence is published.
- Finished nine-strain product, peer-reviewed efficacy trial: none identified.
- Finished nine-strain product, registered study: one identified, NCT07380009 (University of Thessaly), a randomised open-label study of acceptability and adherence to dosing regimens during antibiotic therapy, completed 30 May 2026, no results publication identified.[8]
- Individual components: human studies exist for the two-strain SYNBIO® combination of L. rhamnosus IMC 501 and L. paracasei IMC 502 in healthy adults (for example Verdenelli et al., Lett Appl Microbiol 2011;52(6):596-602), and EFSA assessed that combination in 2015.[13][7] These are studies of two strains at their own doses, not of the finished nine-strain, 460 billion CFU product.
It would be inaccurate to write "Vivomixx neo® has no clinical evidence". Component-level human evidence exists, and a study of the finished product has been registered and completed. It would be equally inaccurate to present the De Simone Formulation's trials, or the SYNBIO® studies, as evidence for the finished Vivomixx neo® formulation. The absence of an identified efficacy trial in a dated search is not proof that none can ever exist, and this section should be read as a snapshot at 18 September 2026.
Evidence for ingredients is not evidence for the finished product
This principle applies equally to every probiotic on the market, including CDS22-formula. A study of one strain, of two strains, at a different dose, or in a different combination is a study of that intervention. It is not automatically a clinical study of a finished multi-strain product that happens to contain those strains among others, in different proportions, at a different total dose.
The reason is the same one that runs through this whole guide. A multi-strain formulation is a defined combination, and its evidence has to be generated with that combination. That is why the WGO and ISAPP frameworks talk about "strains or strain combinations", and why journals correct attribution when a brand name and a formulation part ways.[2]
What to look for when comparing probiotics
The science above reduces to seven questions a UK consumer, pharmacist or clinician can ask of any probiotic. They do not favour one product over another; they favour products whose claims can be checked.
| # | Question to ask | Why it matters |
|---|---|---|
| 1 | Are the strains clearly identified, ideally with culture-collection codes? | Species names alone do not identify a probiotic (WGO 2023). |
| 2 | Is there human research using the finished formulation as sold? | Evidence for components or predecessors is not evidence for the finished product. |
| 3 | What dose was studied, and does it match the label dose? | Trial doses are often higher than retail servings. |
| 4 | Does the research involve the population and outcome you care about? | Evidence is population- and endpoint-specific. |
| 5 | Is the evidence being cited for the current product, or for a historical formulation under the same brand? | Brand continuity is not formulation continuity (ECCO 2024; Cochrane 2020). |
| 6 | Has the formulation changed, and is that documented? | A change in strains or proportions creates a different preparation. |
| 7 | If a higher strain count or CFU total is presented as an advantage, is there comparative evidence? | Neither number is a measure of effect on its own. |
For a broader framework on reading a probiotic label and the published RCT data behind the main UK options, see our clinical probiotics UK evidence guide.
Probiotic formulations in the UK: regulation, VAT and availability
In the United Kingdom, CDS22-formula and Vivomixx neo® are both sold as food supplements. In Great Britain, food supplements are regulated by the Food Standards Agency under food law, and any nutrition or health claim made for them must be an authorised claim under the retained provisions of Regulation (EC) No 1924/2006; in Northern Ireland, EU food law continues to apply under the Windsor Framework, so the GB position should not be assumed to apply identically there.[14] No health claim for a probiotic supplement strain has been authorised in Great Britain or the EU (the only authorised claim involving live cultures concerns yoghurt and lactose digestion), which is why compliant probiotic supplement labels in the UK do not make health claims.
Neither product is a medicine. Neither is licensed by the MHRA, and neither is intended to diagnose, treat, cure or prevent any disease. Food supplements carry 20% VAT in the UK. Anyone with a diagnosed condition, or taking prescribed medicines, should speak to a GP or pharmacist before adding a probiotic food supplement, and NHS advice should take precedence over anything on this page.
CDS22-formula is available in the UK from Probiotic.co.uk, which is the sole exclusive distributor for the United Kingdom and Ireland under a written agreement with the manufacturer, EOS2021 S.r.l. It is dispatched refrigerated from a temperature-controlled facility in Chorley, Lancashire, with tracked next-day delivery across the UK including Northern Ireland. Probiotic.co.uk does not sell Vivomixx neo® and has no affiliation with Mendes S.A.
Product details on this page, including the eight strains and NCIMB codes (30435 to 30442), per-strain CFU, pack size (12 sachets, 450 billion CFU each), storage (refrigerate at 2 to 8°C; shelf-stable up to 7 days at or below 25°C per the manufacturer's leaflet) and price (£22.95 inc. VAT at 20%), were verified by Probiotic.co.uk against the live UK product listing (product handle cds22-formulation-probiotic-450-billion-12-sachets) and current packaging on 18 September 2026. Vivomixx neo® details were taken from the manufacturer's official product pages on the same date. Product details should always be checked against the current label before use, as formulations and pricing may change.
The key takeaway
Probiotic formulations should be judged by what they actually contain and by the evidence generated with that exact formulation. A familiar brand name, an overlapping species list, a similar strain count or a CFU figure a few per cent higher or lower does not replace formulation-specific evidence, and it does not transfer one formulation's clinical record to another.
Applied to the worked example: Vivomixx neo® is a separately declared nine-strain formulation. Based on the manufacturer's listed strain identifiers and quantitative composition, it should not be treated as interchangeable with, or as the same clinical intervention as, the eight-strain De Simone Formulation. This is a formulation-identity conclusion, not a safety, quality or clinical-superiority finding.
The clinical and guideline research discussed in this article relates to the De Simone Formulation as a studied formulation. It should not be read as a claim that CDS22-formula produces these effects. CDS22-formula is a food supplement, not a medicine. This page makes no claim that CDS22-formula prevents, treats or cures any disease, and no specific authorised health claim is made for it.
Learn more about CDS22-formula
If you want to review the composition, the NCIMB strain codes, the storage requirements and the background of CDS22-formula, the full product information is on the listing, and the published research on the De Simone Formulation is indexed on our clinical studies page.
£22.95 for 12 sachets inc. 20% VAT. Not a medicine. Read about the published research on the De Simone Formulation or see the CDS22-formula delivery and cold-chain FAQs.
Frequently asked questions
Are CDS22-formula and Vivomixx neo® the same probiotic formulation?
No. According to the manufacturers' own published composition information, CDS22-formula contains the De Simone Formulation, an eight-strain formulation providing 450 billion CFU per sachet with strains identified by DSM and NCIMB culture-collection codes (DSM 24730-24737 / NCIMB 30435-30442). Vivomixx neo® is declared by Mendes S.A. as a nine-strain formulation providing 460 billion CFU per sachet with different strain identifiers (IMC 502, IMC 501, SP1, Bbr8, BLC1, LA1, 14D, SP38 and SP4). The two products have different declared strain sets, different strain identifiers and different quantitative compositions. That establishes that they are different formulations; it does not by itself establish that either is safer, stronger or more effective than the other.
Does Vivomixx neo® contain the De Simone Formulation?
Not according to the declared compositions. The De Simone Formulation is an eight-strain combination identified by DSM 24730-24737 / NCIMB 30435-30442, and it includes a Lactobacillus helveticus strain (historically named L. delbrueckii subsp. bulgaricus, DSM 24734 / NCIMB 30440). The official Vivomixx neo® composition lists nine strains with IMC, SP, Bbr, BLC, LA and 14D identifiers, includes two Lacticaseibacillus rhamnosus strains and a Lactococcus lactis strain that are not part of the De Simone Formulation, and does not list an L. helveticus strain. Different identifiers alone do not prove that two strains are genetically different, but identity cannot be assumed without authenticated strain mapping or genomic evidence, and we did not identify any such published source in the sources searched on 18 September 2026.
Is a nine-strain probiotic automatically better than an eight-strain probiotic?
No automatic conclusion can be drawn from strain count alone. The World Gastroenterology Organisation's 2023 Global Guideline states that probiotic benefits are most robustly linked to specific strains or strain combinations at the dose actually studied, not to the number of strains. Strain count describes what is in a product; it is not a measure of clinical benefit. Whether a nine-strain formulation performs better, worse or the same as an eight-strain formulation can only be established by human trials of each finished formulation, ideally head to head.
Does 460 billion CFU mean a probiotic is stronger than one with 450 billion CFU?
No. CFU (colony-forming units) is a count of viable micro-organisms per dose. The difference between 460 billion and 450 billion CFU is 10 billion, approximately 2.2%. A CFU total describes quantity, not clinical effect, and higher CFU has not been shown to mean greater effect across probiotics in general (ISAPP consensus, Hill et al., Nat Rev Gastroenterol Hepatol 2014, PMID 24912386). There is no published evidence that the additional 10 billion CFU has any effect, positive or negative, and there is equally no basis for saying it has none.
Why do probiotic strain designations matter?
Because probiotic effects are studied at strain level, not species level. The World Gastroenterology Organisation's 2023 guideline explains that a probiotic strain is identified by genus, species, subspecies where applicable and an alphanumeric strain designation, and that FAO/WHO guidelines ask manufacturers to deposit strains in an internationally recognised culture collection such as DSMZ (DSM codes) or NCIMB. Two products can both state 'Lactobacillus acidophilus' and contain different strains with different properties. A recognised culture-collection accession makes strain-level verification far more transparent; a species name alone usually cannot establish strain identity.
Can clinical studies on one probiotic be applied to another?
Not automatically. Clinical evidence belongs to the intervention actually studied: the specific strains, their proportions, the dose, the population and the endpoint. Overlapping species, a similar CFU total, a related brand name or a similar number of strains do not transfer that evidence to a differently composed product. Journals have issued formal corrections on exactly this point: the European Crohn's and Colitis Organisation (J Crohns Colitis 2023;17(1):149, amended 2 January 2024) and the Cochrane Collaboration (CD007443, amended 4 May 2020) both clarified that studies performed on the De Simone Formulation should not be attributed to a later product carrying the same historical brand name.
What is the De Simone Formulation?
The De Simone Formulation is a specific eight-strain, high-concentration probiotic formulation developed by Professor Claudio De Simone. Its eight strains are identified by culture-collection codes DSM 24730-24737 and NCIMB 30435-30442: Streptococcus thermophilus, Bifidobacterium breve, two Bifidobacterium animalis subsp. lactis strains (historically named B. longum and B. infantis), Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus paracasei and Lactobacillus helveticus (historically L. delbrueckii subsp. bulgaricus). According to the ECCO correction amended on 2 January 2024, it was sold as VSL#3® until 2016 and the VSL#3® product no longer contains it after 2016. It has also been marketed as Vivomixx® in Europe and Visbiome® in the United States, and is currently marketed as CDS22-formula.
What is CDS22-formula?
CDS22-formula is a food supplement manufactured by EOS2021 S.r.l. that, according to the manufacturer, contains the De Simone Formulation. Each 450 billion CFU sachet lists eight strains by NCIMB code on the UK label: Streptococcus thermophilus NCIMB 30438 (226 billion CFU), Bifidobacterium breve NCIMB 30441 (24 billion), Bifidobacterium animalis subsp. lactis NCIMB 30435 and NCIMB 30436 (24 billion each), Lactobacillus acidophilus NCIMB 30442, Lactobacillus plantarum NCIMB 30437, Lactobacillus paracasei NCIMB 30439 and Lactobacillus helveticus NCIMB 30440 (38 billion each). A 112 billion CFU capsule format also exists. The statement that CDS22-formula contains the De Simone Formulation is a manufacturer statement; no clinical trial has been published under the CDS22-formula product name. It is a food supplement, not a medicine.
What clinical evidence exists for Vivomixx neo®?
As at 18 September 2026, Probiotic.co.uk's own search of PubMed, ClinicalTrials.gov and the manufacturer's published materials did not identify a peer-reviewed human efficacy trial of the complete nine-strain, 460 billion CFU Vivomixx neo® formulation. One registered study of Vivomixx neo® 460 was identified (NCT07380009, University of Thessaly, randomised open-label, completed 30 May 2026); its registered primary outcomes concern acceptability and adherence to dosing regimens during antibiotic therapy rather than a clinical efficacy endpoint, and no publication of its results was identified. Human studies do exist for the two-strain SYNBIO® combination (L. rhamnosus IMC 501 plus L. paracasei IMC 502), which are components of Vivomixx neo®, but those are not trials of the finished nine-strain product. The absence of an identified trial in a dated search is not proof that none will ever exist.
How is CDS22-formula regulated in the UK?
CDS22-formula is sold in the United Kingdom as a food supplement. In Great Britain, food supplements fall under Food Standards Agency food law and the retained provisions of Regulation (EC) No 1924/2006 on nutrition and health claims; in Northern Ireland, EU food law continues to apply under the Windsor Framework. It is not a medicine and is not licensed by the MHRA. This guide makes no claim that it prevents, treats or cures any disease, and no specific authorised health claim is made for it. Food supplements are subject to 20% VAT in the UK.
Where can I buy CDS22-formula in the UK?
CDS22-formula is available in the UK from Probiotic.co.uk, the sole exclusive distributor for the United Kingdom and Ireland appointed under written agreement with the manufacturer EOS2021 S.r.l. The 12-sachet pack (450 billion CFU per sachet) is listed at £22.95 including 20% VAT as at 18 September 2026, with tracked next-day cold-chain delivery from Chorley, Lancashire. The product should be refrigerated at 2 to 8°C and is shelf-stable for up to seven days at or below 25°C according to the manufacturer's leaflet.
Are high-strength multi-strain probiotics safe, and what dose is on the label?
High-strength multi-strain probiotics are sold as food supplements and have been used in published human trials at doses up to 900 billion CFU three times daily for three weeks (Damianos et al., Mayo Clinic, Aliment Pharmacol Ther 2026, PMID 42487516, n=24). The CDS22-formula label directs adults to take 1 to 2 sachets per day; directions for children are on the label. A trial dose is not the same as a label dose. People who are immunocompromised, seriously ill, pregnant, breastfeeding or taking prescribed medicines should speak to a GP or pharmacist before taking any probiotic food supplement. Always follow the current label.
- A probiotic formulation is defined by its specific strains, their proportions, the dose, and the manufacturing and stability process, not by brand name, species list or CFU total alone.
- A probiotic strain is identified by genus, species, subspecies and an alphanumeric strain designation; strain designations, product names and trade names are not controlled by the scientific community (World Gastroenterology Organisation Global Guideline, February 2023).
- Probiotic benefits are most robustly linked to specific strains or strain combinations at the studied dose (WGO 2023; ISAPP consensus, Hill et al., 2014, PMID 24912386).
- Clinical evidence belongs to the formulation actually studied and does not automatically transfer to a differently composed product; ECCO (amended 2 January 2024) and Cochrane (4 May 2020) issued corrections making this point about the De Simone Formulation.
- The De Simone Formulation is an eight-strain, 450 billion CFU formulation identified by DSM 24730-24737 / NCIMB 30435-30442; it was sold as VSL#3® until 2016 and is currently marketed as CDS22-formula.
- Vivomixx neo® (Mendes S.A.) is declared as a nine-strain, 460 billion CFU formulation, described on the UK Vivomixx® website as "a revised formulation"; IMC 502 and IMC 501 account for 380 of 460 billion CFU (82.6%), and total L. rhamnosus is 216 billion CFU (47.0%).
- 460 billion CFU versus 450 billion CFU is a difference of 10 billion, approximately 2.2%; it describes quantity, not clinical effect.
- CDS22-formula and Vivomixx neo® share no public strain identifier and have different declared strain sets and proportions; this establishes that they are different formulations, not that either is superior.
- A 2026 randomised, double-blind, placebo-controlled trial (Damianos et al., Mayo Clinic, PMID 42487516, n=24) identified its intervention as the eight-strain De Simone Formulation; it does not establish a consumer health claim for CDS22-formula.
- As at 18 September 2026, no peer-reviewed human efficacy trial of the complete nine-strain Vivomixx neo® formulation was identified; one registered acceptability and adherence study (NCT07380009) was identified, and component-level SYNBIO® studies exist.
- In the UK, CDS22-formula and Vivomixx neo® are food supplements regulated by the FSA, not medicines; 20% VAT applies.
- CDS22-formula (12 sachets, 450 billion CFU each, £22.95) is available from Probiotic.co.uk, the sole exclusive UK and Ireland distributor, with tracked next-day cold-chain delivery from Chorley, Lancashire.
Related guides
This guide was prepared by Probiotic.co.uk using the following process:
- Reviewed the primary sources on strain identity and evidence attribution: the WGO Global Guideline on Probiotics and Prebiotics (February 2023), the ISAPP consensus statement (Hill et al., 2014), the AGA 2024 pouchitis guideline (Barnes et al.), the ECCO correction amended 2 January 2024, the Cochrane CD007443 amendment of 4 May 2020, the EFSA 2015 SYNBIO® opinion and the Damianos et al. 2026 randomised trial.
- Used Professor Claudio De Simone's published August 2026 comparison and open letters as a starting point, then checked each numerical and evidential statement against the primary sources above rather than repeating them.
- Took the Vivomixx neo® composition and per-strain quantities from Mendes S.A.'s official product pages, and the CDS22-formula composition from the live UK listing and manufacturer information, on 18 September 2026.
- Verified the PMIDs cited in this guide (24912386, 38128971, 35971821, 42487516, 32128794) against PubMed and checked the DOIs and registry entries (NCT06609148, NCT07380009) before publishing.
- Independently searched PubMed and ClinicalTrials.gov records and the manufacturer's and UK distributor's product pages on 18 September 2026 for human trials of the finished nine-strain Vivomixx neo® formulation, published the search method on this page, and reported the result, including the registered study NCT07380009, rather than relying on the August 2026 source review alone.
- Checked FSA food supplement rules and the retained Regulation (EC) No 1924/2006 framework for UK compliance, and kept the article free of disease-treatment claims for any product.
- Labelled figures as manufacturer-declared, editorial calculation or not established, so that a reader can see which statements are sourced facts and which are arithmetic derived from them.
- Left out the US court judgments referred to in the source materials, because they concern US law and US-marketed products and do not materially improve a UK reader's understanding of formulation identity.
This guide is for educational purposes only and does not constitute medical advice. CDS22-formula is a food supplement and is not intended to diagnose, treat, cure, or prevent any disease or medical condition. The NHS recommends seeing a GP if digestive symptoms persist for more than 3 weeks, and anyone with a diagnosed condition, or taking prescribed medicines, should speak to a GP or pharmacist before taking any food supplement. Statements about any product named here are limited to publicly available product information and published sources consulted on 18 September 2026 and to what those sources do or do not show. The absence of an identified human trial in a dated search is not proof that none can ever exist. Manufacturers may update specifications; readers should verify the current label and official product information. Probiotic.co.uk is regulated under UK food supplement legislation.
Trade marks. Vivomixx® and Vivomixx neo® are registered trade marks of Mendes S.A., Via S. Balestra 10, 6900 Lugano, Switzerland (Vivomixx neo®: EU trade mark No. 019057715). VSL#3® is a registered trade mark of VSL Pharmaceuticals, Inc. and Actial S.r.l. Visbiome® is a trade mark of ExeGi Pharma, LLC. SYNBIO® is a trade mark of its proprietor. CDS22-formula is manufactured by EOS2021 S.r.l. These marks are referred to for identification only; their use here implies no affiliation with, sponsorship by, or endorsement by their proprietors, and nothing on this page should be read as a claim that CDS22-formula is, continues to be, or is a version of any of those branded products. Probiotic.co.uk is not affiliated with, endorsed by or connected to Mendes S.A., VSL Pharmaceuticals, Inc., Actial S.r.l. or ExeGi Pharma, LLC. Probiotic.co.uk sells CDS22-formula and is not a neutral party on this subject.
Sources
- [Peer-reviewed consensus] Hill C, Guarner F, Reid G, et al. Expert consensus document: The International Scientific Association for Probiotics and Prebiotics consensus statement on the scope and appropriate use of the term probiotic. Nat Rev Gastroenterol Hepatol. 2014;11(8):506-514. PMID 24912386. DOI 10.1038/nrgastro.2014.66. — pubmed.ncbi.nlm.nih.gov/24912386
- [Clinical guideline] Guarner F, Sanders ME, Szajewska H, et al. World Gastroenterology Organisation Global Guidelines: Probiotics and Prebiotics. February 2023. Also published in J Clin Gastroenterol. 2024;58(6):533-553. DOI 10.1097/MCG.0000000000002002. — worldgastroenterology.org
- [Clinical guideline] Barnes EL, Agrawal M, Syal G, et al. AGA Clinical Practice Guideline on the Management of Pouchitis and Inflammatory Pouch Disorders. Gastroenterology. 2024;166(1):59-85. PMID 38128971. — pubmed.ncbi.nlm.nih.gov/38128971
- [Journal correction] European Crohn's and Colitis Organisation. Correction (references to VSL#3® and the De Simone Formulation), published 16 August 2022, amended 2 January 2024. J Crohns Colitis. 2023;17(1):149. PMID 35971821. PMC10060704. DOI 10.1093/ecco-jcc/jjac104. — pmc.ncbi.nlm.nih.gov/articles/PMC10060704
- [Peer-reviewed RCT] Damianos JA, Matar A, Carlson P, Busciglio I, Jencks KJ, Johnson S, Mars RA, Kashyap PC, Harmsen WS, Camilleri M. Clinical Trial: Multi-Strain Probiotic Improves Bile Acid Profile, Microbiome, and Metabolomic Parameters in Patients With History of Bile Acid Malabsorption: A Randomized, Controlled Trial. Aliment Pharmacol Ther. 2026;64(6):748-757. PMID 42487516. PMC13511384. DOI 10.1111/apt.70876. ClinicalTrials.gov NCT06609148. — pubmed.ncbi.nlm.nih.gov/42487516
- [Systematic review, correction] Iheozor-Ejiofor Z, Kaur L, Gordon M, Baines PA, Sinopoulou V, Akobeng AK. Probiotics for maintenance of remission in ulcerative colitis. Cochrane Database Syst Rev. 2020;3(3):CD007443 (correction amended 4 May 2020). PMID 32128794. PMC7059960. DOI 10.1002/14651858.CD007443.pub3. — pmc.ncbi.nlm.nih.gov/articles/PMC7059960
- [Regulatory opinion] EFSA Panel on Dietetic Products, Nutrition and Allergies. Scientific Opinion on the substantiation of a health claim related to SYNBIO®, a combination of Lactobacillus rhamnosus IMC 501® and Lactobacillus paracasei IMC 502®, and maintenance of normal defecation pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA Journal. 2015;13(5):4095. DOI 10.2903/j.efsa.2015.4095. — doi.org/10.2903/j.efsa.2015.4095
- [Trial registry] ClinicalTrials.gov. NCT07380009: Acceptability and Adherence to Different Dosing Regimens of the Multistrain Probiotic Vivomixx Neo® 460 in Adults Receiving Antibiotic Therapy: a Randomized, Open-label Clinical Trial. University of Thessaly. Completed 30 May 2026. — clinicaltrials.gov/study/NCT07380009
- [Manufacturer-declared composition] Mendes S.A. Vivomixx neo® 9 - 460 billion: official product information, strain list and per-strain CFU. Accessed 18 September 2026. — neo.vivomixx.eu/vivomixx-neo-460-billion
- [Retailer listing, current label] Probiotic.co.uk. CDS22-formula 450 Billion CFU, 12 sachets: UK product listing with NCIMB strain codes and per-strain CFU. Accessed 18 September 2026. — probiotic.co.uk/products/cds22-formulation-probiotic-450-billion-12-sachets
- [Manufacturer information] CDS22-formula. Composition and DSM/NCIMB cross-reference (official manufacturer information page, Poland). — cds22.com.pl/kompozycja-i-sklad-cds22
- [Trial registry protocol] ClinicalTrials.gov. NCT03369431: Efficacy of Vivomixx® on Behaviour and Gut Function in Autism Spectrum Disorder. Study protocol (University College London Hospitals) listing Vivomixx® as eight strains, DSM 24730-24737, 450 billion per sachet. — cdn.clinicaltrials.gov (NCT03369431 protocol)
- [Peer-reviewed study] Verdenelli MC, Silvi S, Cecchini C, Orpianesi C, Cresci A. Influence of a combination of two potential probiotic strains, Lactobacillus rhamnosus IMC 501® and Lactobacillus paracasei IMC 502® on bowel habits of healthy adults. Lett Appl Microbiol. 2011;52(6):596-602. PMID 21395626. — pubmed.ncbi.nlm.nih.gov/21395626
- [Regulator guidance] Food Standards Agency. Food supplements: business guidance. — food.gov.uk/business-guidance/food-supplements
- [UK distributor website] Vivomixx® UK website (Gastropharm Ltd). "What is Vivomixx Neo?" page describing Vivomixx neo® as "a revised formulation" with nine strains. Accessed 18 September 2026. — vivomixx.co.uk/about-vivomixx-neo
Source types: peer-reviewed research and clinical guidelines are treated as primary scientific evidence; regulator opinions and guidance as regulatory sources; trial registries as records of registered studies; manufacturer, distributor and retailer pages as declared composition and product information, not as independent scientific evidence.