VSL#3 Alternatives in Ireland: The De Simone Formulation Explained
VSL#3 Alternatives in Ireland:
The De Simone Formulation Explained
Irish consumers researching alternatives to VSL#3 often encounter the term "De Simone Formulation". This guide sets out what the term means, what ECCO and the AGA have published about it, and what the US courts found.
VSL#3® is a registered trademark of VSL Pharmaceuticals Inc. and Actial S.r.l. Vivomixx® is a registered trademark of Mendes SA. Visbiome® is a registered trademark of ExeGi Pharma. CDS22-formula is manufactured by EOS2021 S.r.l. These are independent companies and are not affiliated with each other.
Probiotic.ie and CDS22-formula are not affiliated with, endorsed by, sponsored by, connected to or distributed by the holders of the VSL#3, Vivomixx or Visbiome trademarks. Those brand names are referred to on this page for identification and historical reference only. CDS22-formula is a separate product sold in competition with them. 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.
This page is commercial in nature. Probiotic.ie sells CDS22-formula and is not a neutral party on this subject. Every statement below is attributed to the organisation that published it. Probiotic.ie has not independently verified any of them and does not represent the position of any other company. Readers should consult the linked primary sources directly rather than rely on this summary, and should obtain current specifications from the relevant manufacturer before drawing any conclusion about a product.
| Question | Published position | Source |
|---|---|---|
| What has ECCO published about VSL#3 and the De Simone Formulation? | ECCO stated in October 2023 that after 2016 the product sold as VSL#3 no longer contains the De Simone Formulation. | ECCO Official Statement, ECCO News Vol 18 Issue 3, 26 Oct 2023 |
| What does the CDS22 manufacturer state about its formulation? | EOS2021 S.r.l. states that CDS22-formula contains the De Simone Formulation. A manufacturer statement, not an independent finding. | Manufacturer's own statement, cds22.com. Not an independent source. |
| Which probiotic is cited in the AGA pouchitis guideline? | The De Simone Formulation specifically. The recommendation is conditional, based on low-certainty evidence, and applies to secondary prevention of recurrent pouchitis only. | AGA Guideline, Gastroenterology 2024 (PMID 38128971) |
| What did the US false-advertising litigation find? | A Maryland jury found in 2018 that claims of equivalence between the post-2016 US VSL#3 product and the earlier formulation were false and misleading under the US Lanham Act. The Fourth Circuit affirmed that verdict in 2021, while holding part of the resulting injunction overbroad and vacating it in part. Those proceedings concerned the US-marketed product and were decided under US law. They are not a ruling of any Irish or EU court. | US 4th Circuit Court, 2021 |
What Does "De Simone Formulation" Mean?
"De Simone Formulation" is the term used in the clinical literature for a specific 8-strain probiotic blend developed by Professor Claudio De Simone, an Italian clinician and researcher. Trials using this blend were published in Gastroenterology and Gut from 2000 onwards. The 2024 ESPEN attribution paper in Clinical Nutrition was written specifically to clarify how this formulation should be attributed in published research.[2a]
ECCO states that until 2016 this formulation was sold under the VSL#3 brand, and that a commercial separation then took place between Professor De Simone and the VSL#3 brand owner. According to ECCO, the VSL#3 brand name continued, but the product sold under it after 2016 no longer contains the De Simone Formulation.[2]
In parallel US litigation, a Maryland jury found in 2018 that claims of equivalence between the post-2016 US VSL#3 product and the earlier formulation were false and misleading under the US Lanham Act. The Fourth Circuit affirmed that verdict in February 2021, while holding part of the resulting injunction overbroad and vacating it in part.[1] That litigation concerned the product marketed in the United States and was decided under US law. It is not a ruling of any Irish or EU court and it does not determine the composition of any product currently sold in Ireland.
Probiotic.ie is not in a position to represent the current position of any company named on this page. Statements above are reproduced from documents those organisations published themselves. If a specific point matters to you, read the source document and contact the manufacturer concerned directly.
Regulatory Context in Ireland
In Ireland, probiotics are sold as food supplements under Irish and EU food law, enforced by the Food Safety Authority of Ireland (FSAI). Medicines are regulated separately by the HPRA. A probiotic sold as a food supplement is not a medicine and carries no authorised health claim unless one has been approved under EU Regulation 1924/2006.
Neither the FSAI nor the HPRA endorses any probiotic brand. Clinical guidelines published by bodies such as ECCO and the AGA are referred to by clinicians internationally, but those guidelines refer to formulations as studied in the literature, not to retail products, and they are not endorsements of anything sold in an Irish shop.
Discuss any change of product with the clinician who made the recommendation before switching. Brand names, formulations and labels have all changed since 2016, and this page is written by a retailer, not a healthcare provider. If you have persistent or worsening digestive symptoms, speak to your GP. The HSE publishes general health guidance for Irish patients.
Brand History Timeline: 2016 to 2026
The Clinical Evidence Base Is Built
Trials by Gionchetti et al. (2000, 2003) in Gastroenterology and Mimura et al. (2004) in Gut establish the evidence base later referenced in ECCO IBD guidelines and the AGA pouchitis guideline.
Commercial Separation
Professor De Simone separated from the VSL#3 brand owner. In the subsequent US litigation, the federal court record treated ownership of the formulation Know-How as remaining with Professor De Simone, while the VSL#3 trade name remained with the former licence partner. ECCO states that from this date the VSL#3 brand and the De Simone Formulation should be treated as distinct.[2]
Vivomixx 450 (Ireland and EU) and Visbiome (US)
The formulation is marketed as Vivomixx 450 in Ireland and the EU by Mendes SA, and as Visbiome in the United States by ExeGi Pharma. Irish consumers accessing the formulation during this period did so through Vivomixx 450 sachets and capsules.
Vivomixx Neo Introduced
Mendes SA launches Vivomixx Neo under the Vivomixx brand name and presents it as a separate product from the earlier Vivomixx 450. For the current status and specification of either product, refer to Mendes SA's own published product information. Irish consumers should not assume that a shared brand name means a shared formulation, in either direction.
CDS22-Formula Enters the Irish Market
CDS22-formula is launched by EOS2021 S.r.l. Its manufacturer states that it contains the De Simone Formulation, at 450 billion CFU per sachet. The current Irish label lists eight strains under NCIMB codes, set out in the table below. These are the manufacturer's own statements about its product and Probiotic.ie has not independently verified them.[3]
What ECCO and the AGA Have Published
Two clinical bodies have published material that refers to the De Simone Formulation by name. Both are set out below in their own terms. Neither body endorses any retail product, and neither has any connection to Probiotic.ie.
ECCO (European Crohn's and Colitis Organisation)
ECCO has clarified: (1) Until 2016, the De Simone Formulation was sold as VSL#3. (2) After 2016, the product sold as VSL#3 no longer contains the De Simone Formulation. (3) VSL#3 references in ECCO's 2017 IBD guidelines relate to the De Simone Formulation. Source: ECCO Official Statement, 26 October 2023.[2]
The statement was published in ECCO News, Volume 18, Issue 3, October 2023. The copy linked here is hosted on the manufacturer's website. Readers who wish to verify it should obtain the statement from ECCO directly.
Read the ECCO statement directly rather than rely on any retailer's summary of it, including ours.
AGA (American Gastroenterological Association)
The AGA guideline (Barnes EL et al., Gastroenterology 2024;166(1):59-85, PMID 38128971) identifies the De Simone Formulation as the multi-strain probiotic used in the trials it reviewed for secondary prevention of recurrent pouchitis. The guideline states that the probiotic evidence for preventing recurrence of pouchitis is limited to the De Simone Formulation. The recommendation is conditional, based on low-certainty evidence, and applies to secondary prevention of recurrent pouchitis only.
In the underlying maintenance trial (Gionchetti et al., 2000, PMID 10930365), 15% of patients on the formulation relapsed over the study period, compared with 100% on placebo. Source: PubMed (PMID 38128971).[4]
Note: these guideline references relate to the De Simone Formulation as a studied formulation. They are not an endorsement of CDS22-formula or of any other retail product, and no clinical trial has been conducted on CDS22-formula under that name.
These figures relate to the De Simone Formulation as described in the published literature. The trial and publication counts are as stated by the manufacturer, EOS2021 S.r.l., in its published bibliography of the De Simone Formulation literature, and Probiotic.ie has not independently verified them. No clinical trial has been conducted on CDS22-formula under that product name. These figures are not a claim that CDS22-formula treats, cures or prevents any condition. The CFU and strain-count figures are taken from the current Irish pack label.
The Current CDS22-Formula Irish Label, Strain by Strain
The table below sets out the eight strains as they appear on the current CDS22-formula Irish label, alongside the pre-2016 names used in the published research.
We make no assertions about the composition of any other product. We have not tested any product and other manufacturers' strain designations and sourcing cannot be independently verified by us. Anyone wanting to compare products should obtain current specifications directly from each manufacturer. A deposit code appearing on a product label does not by itself establish that two commercial products have identical organisms, proportions, manufacturing processes or clinical equivalence.
Three organisms in the formulation were reclassified under updated bacterial taxonomy. The two strains once listed as Bifidobacterium longum and Bifidobacterium infantis are now classified as Bifidobacterium animalis subsp. lactis (NCIMB 30435 and NCIMB 30436). The strain once listed as Lactobacillus delbrueckii subsp. bulgaricus is now classified as Lactobacillus helveticus (NCIMB 30440). These are naming changes only, consistent with the taxonomic revision published by Zheng et al. (Int J Syst Evol Microbiol, 2020;70(4):2782-2858).
| Name used in the pre-2016 research | Current CDS22-formula Irish label (NCIMB code) | CFU per sachet |
|---|---|---|
| Streptococcus thermophilus | Streptococcus thermophilus (NCIMB 30438) | 226 billion |
| Bifidobacterium breve | Bifidobacterium breve (NCIMB 30441) | 24 billion |
| Bifidobacterium longum (reclassified) | Bifidobacterium animalis subsp. lactis (NCIMB 30435) | 24 billion |
| Bifidobacterium infantis (reclassified) | Bifidobacterium animalis subsp. lactis (NCIMB 30436) | 24 billion |
| Lactobacillus acidophilus | Lactobacillus acidophilus (NCIMB 30442) | 38 billion |
| Lactobacillus plantarum | Lactobacillus plantarum (NCIMB 30437) | 38 billion |
| Lactobacillus paracasei | Lactobacillus paracasei (NCIMB 30439) | 38 billion |
| L. delbrueckii subsp. bulgaricus (reclassified) | Lactobacillus helveticus (NCIMB 30440) | 38 billion |
| Total live cultures per sachet | 450 billion |
CDS22-formula NCIMB strain codes and CFU figures are taken from the current Irish product label and manufacturer documentation supplied by EOS2021 S.r.l. Probiotic.ie has not independently tested any product. Strain designations, sourcing and specifications change; always verify against current manufacturer documentation before making any clinical decision, and discuss clinical decisions with a qualified healthcare professional.
How to Check Formulation Identity Yourself
Rather than relying on brand names or on any retailer's summary, including ours, you can check the position yourself using publicly available sources.
Five-step verification process
- Read the ECCO statement in full. ECCO published its position in October 2023. The attribution question is also addressed in the 2024 ESPEN paper in Clinical Nutrition. Read both directly rather than relying on a summary.
- Compare strains and codes, not species names alone. The current CDS22-formula Irish label lists its strains under NCIMB codes (NCIMB 30435 to NCIMB 30442). Check the strain names and codes on the current product label rather than relying on the brand name. A code on a label does not by itself establish equivalence between two commercial products.
- Check the published trial you are relying on by its PMID, and note which formulation and dose it used, and in which patient population.
- Contact each manufacturer directly and treat every one as an interested party. Each manufacturer has a commercial interest in the outcome, including the one we distribute. None of their statements is an independent verification. Where a specific claim matters to you, ask that manufacturer for the underlying documentation rather than relying on a website summary.
- Discuss any clinical decision with your GP or gastroenterologist. This page is not medical advice.
The Irish Market in 2026
| Product | Manufacturer's stated position | Status in 2026 | Irish Availability |
|---|---|---|---|
| CDS22-formula | EOS2021 S.r.l. states it contains the De Simone Formulation | Current | Available from Probiotic.ie |
| Visbiome (US) | ExeGi Pharma states it contains the De Simone Formulation | Current | US market only |
| Vivomixx 450 | Was marketed by Mendes SA as containing the De Simone Formulation. Refer to Mendes SA for its current status. | Refer to Mendes SA | Refer to Mendes SA |
| VSL#3 (current) | Not asserted here. See the ECCO statement linked above, and contact the brand owner directly for current specifications. | Current | Available in Ireland |
| Vivomixx Neo | Presented by Mendes SA as a separate product from Vivomixx 450 | Current | Available in Ireland |
The material above comes from different organisations, published at different times, for different purposes. ECCO published a clarification in 2023. A US jury reached a finding under US false-advertising law in 2018, affirmed on appeal in 2021 with part of the injunction held overbroad. EOS2021 S.r.l. states that CDS22-formula contains the De Simone Formulation. Probiotic.ie sells CDS22-formula, has not independently verified any of these statements, and is not in a position to represent the position of any other company. We have linked the primary sources so that you can read each document directly, obtain current specifications from the relevant manufacturer, and reach your own view, ideally with your clinician.
The clinical research and guideline references in this guide relate to the De Simone Formulation as a studied formulation. They are not a claim that CDS22-formula treats, cures, or prevents any disease, and no clinical trial has been conducted on CDS22-formula under that product name. CDS22-formula is a food supplement, not a medicine. No authorised EU or Irish health claim is made for it on this page. Probiotic.ie sells CDS22-formula and is not a neutral party on this subject.
CDS22-formula from Probiotic.ie
450 billion CFU per sachet. Eight strains listed under NCIMB codes. Held refrigerated and dispatched on a tracked service from Dublin.
✓ Shop CDS22-formulaVSL#3 Alternatives in Ireland: Common Questions
No. Probiotic.ie is an independent Irish retailer and the authorised Irish distributor of CDS22-formula, which is manufactured by EOS2021 S.r.l. We have no affiliation, endorsement, sponsorship or distribution relationship with the holders of the VSL#3, Vivomixx or Visbiome trademarks. We refer to those brand names for identification and historical reference only.
Most are looking for the formulation described in the clinical literature as the De Simone Formulation. ECCO stated in October 2023 that this formulation was sold under the VSL#3 brand until 2016 and that the product sold as VSL#3 after 2016 no longer contains it. On ECCO's stated position, consumers looking for that formulation should compare strain lists and deposit codes on the current pack rather than rely on the brand name. CDS22-formula is one product on the Irish market whose manufacturer, EOS2021 S.r.l., states it contains the De Simone Formulation. Probiotic.ie has not independently verified that statement. Read the primary sources and request current specifications from each manufacturer before deciding.
In its official statement of 26 October 2023, published in ECCO News Volume 18 Issue 3, ECCO stated that until 2016 the De Simone Formulation was sold under the VSL#3 brand, and that after a commercial separation the product sold as VSL#3 no longer contains that formulation. ECCO stated that the VSL#3 references in its 2017 IBD guidelines should be read as relating to the De Simone Formulation. ECCO does not reference CDS22-formula and does not endorse any retail product. Read the statement in full rather than relying on this summary.
Both refer to the De Simone Formulation by name rather than to a retail brand. The AGA 2024 pouchitis guideline (Barnes et al., Gastroenterology 166(1):59-85, PMID 38128971) identifies the De Simone Formulation as the probiotic used in the trials supporting its recommendation, and states that the probiotic evidence for preventing recurrent pouchitis is limited to that formulation. The AGA recommendation is conditional, based on low-certainty evidence, and applies to secondary prevention of recurrent pouchitis only. Neither body endorses any retail product.
The current Irish label lists eight strains under NCIMB codes NCIMB 30435 to NCIMB 30442, at 450 billion CFU per sachet. Under updated bacterial taxonomy three organisms were reclassified: the former B. longum and B. infantis are now B. animalis subsp. lactis, and the former L. delbrueckii subsp. bulgaricus is now L. helveticus. These are naming changes rather than changes to the organisms, consistent with the taxonomic revision published by Zheng et al. (Int J Syst Evol Microbiol, 2020). Probiotic.ie makes no assertion here about the composition of any other product.
Read the ECCO October 2023 statement in full, compare strain names and deposit codes on the current product label rather than relying on the brand name, and request current specifications directly from each manufacturer. A deposit code appearing on a product label does not by itself establish that two commercial products have identical organisms, proportions, manufacturing processes or clinical equivalence. Every manufacturer is an interested party in this subject, including the one Probiotic.ie distributes, so read each position in its own words rather than relying on any retailer's summary, including ours.
Yes. CDS22-formula is sold in Ireland as a food supplement under Irish and EU food law, regulated by the Food Safety Authority of Ireland. It is not a medicine, it is not authorised by the HPRA, and no prescription is required. No authorised EU or Irish health claim is made for it.
CDS22-formula is available from Probiotic.ie, the authorised Irish distributor. Stock is held refrigerated at a temperature-controlled facility in Dublin and dispatched on a tracked service across Ireland. Per the manufacturer's storage leaflet the product is shelf-stable at room temperature up to 25°C for up to seven days, which covers normal Irish transit, so orders ship without ice packs. Refrigerate on arrival. Free tracked Irish delivery on orders over €75. CDS22-formula is a food supplement, not a medicine.
Further Reading
This guide was prepared by Probiotic.ie using the following process. We reviewed the primary sources on the De Simone Formulation, including the AGA 2024 pouchitis guideline (Barnes et al., PMID 38128971), the ECCO statement of 26 October 2023, the 2024 ESPEN attribution paper in Clinical Nutrition, and the published US Fourth Circuit judgment. We cited the AGA guideline by its PubMed identifier and linked it to PubMed. We attributed every statement to the organisation that published it, and we have not characterised the position of any company that has not published that position itself. We listed the current CDS22-formula strains using the NCIMB codes on the current Irish label with a note on the taxonomy reclassification, and we made no assertion about the composition of any other product. We have not independently tested or verified any product or statement referred to on this page. We checked the content against FSAI food supplement rules for Irish compliance and made no disease-treatment claims for any supplement. This page was reviewed and amended on 31 July 2026 following an external legal review of the statements it contains. Probiotic.ie sells CDS22-formula and has a commercial interest in this subject.
Sources and References
- [1] US Court of Appeals for the Fourth Circuit, February 2021, affirming the false-advertising verdict while vacating part of the injunction as overbroad · caselaw.findlaw.com
- [2] ECCO Official Statement on the De Simone Formulation and VSL#3, 26 October 2023 (ECCO News, Vol 18, Issue 3). Copy hosted on the manufacturer's website; obtain from ECCO directly to verify · full statement (PDF)
- [2a] ESPEN. Clarifying correct attributions in scientific literature: the case of the De Simone Formulation and VSL#3. Clinical Nutrition. 2024. DOI: 10.1016/j.clnu.2024.05.022 · doi.org
- [3] EOS2021 S.r.l., manufacturer of CDS22-formula: the manufacturer's own published position. An interested party, not an independent source · cds22.com
- [4] Barnes EL et al. AGA Clinical Practice Guideline on the Management of Pouchitis and Inflammatory Pouch Disorders. Gastroenterology. 2024 Jan;166(1):59-85. PMID 38128971 · PubMed
- [5] Gionchetti P et al. Oral bacteriotherapy as maintenance treatment in patients with chronic pouchitis. Gastroenterology. 2000;119(2):305-309. PMID 10930365 · pubmed.ncbi.nlm.nih.gov
- [6] Zheng J et al. A taxonomic note on the genus Lactobacillus. Int J Syst Evol Microbiol. 2020;70(4):2782-2858. PMID 32293557 · PubMed
- [7] US Fourth Circuit Court (2022): Claudio De Simone v. VSL Pharmaceuticals · law.justia.com
- [8] FSAI guidance on food supplements · fsai.ie