NutriDex

The Supplement Research Compendium
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De Simone Formulation (VSL#3 / Visbiome)

8-strain high-dose blend

High-dose 8-strain blend with the best gut-microbiome RCT evidence base for pouchitis and ulcerative colitis

Strong evidence 🦠Probiotics🛡️Gut & Immune

✚ Updated · How we grade evidence

Evidence tier
Strong
Research weight
Citations
8 verified / 8
Classification
Probiotics
❝
What the evidence says. Multiple high-quality RCTs / meta-analyses with consistent effects.

What is De Simone Formulation (VSL#3 / Visbiome)?

De Simone Formulation (VSL#3 / Visbiome) (8-strain high-dose blend) is a probiotic strain used for maintains remission in chronic/recurrent pouchitis (best-supported, aga-guideline-endorsed indication). NutriDex grades the human evidence as Strong. The De Simone Formulation (originally sold as VSL#3, now as Visbiome) is a high-dose 8-strain blend with the most robust trial evidence of any probiotic in inflammatory bowel conditions. Its best-supported, guideline-endorsed indication is maintaining remission in chronic/recurrent pouchitis, where double-blind RCTs show dramatic relapse reductions versus placebo. High-quality RCTs also support inducing and maintaining remission in mild-to-moderate ulcerative colitis as an adjunct, and secondary prophylaxis of hepatic encephalopathy in cirrhosis. Evidence in IBS is weaker and largely limited to bloating/flatulence. Note: since 2016 the original De Simone strains are sold only as Visbiome; current VSL#3 is a reformulated product, so older trial data apply specifically to this formulation.

Purported Benefits

✓Maintains remission in chronic/recurrent pouchitis (best-supported, AGA-guideline-endorsed indication)
✓Induces and maintains remission in mild-to-moderate ulcerative colitis as add-on to standard therapy
✓Secondary prophylaxis of hepatic encephalopathy in cirrhosis — fewer HE hospitalizations
✓Reduces liver disease severity and overall hospitalization in cirrhosis
✓Eases bloating and flatulence in IBS (effect on abdominal pain is inconsistent)

Evidence by outcome

The same supplement can be well-proven for one use and unproven for another — here is the human evidence graded outcome by outcome.

OutcomeEvidenceEffectStudies
Maintenance of remission in chronic/recurrent pouchitisTwo double-blind RCTs show dramatic relapse reduction (85% vs 6%), but trials are small and single-formulation. Strong ↑ benefit · large 2
Inducing/maintaining remission in mild-to-moderate ulcerative colitis (adjunct)Multiple RCTs (adult and pediatric) show higher remission/UCDAI response as add-on to standard therapy. Strong ↑ benefit · moderate 3
Secondary prophylaxis of hepatic encephalopathy in cirrhosisOne RCT plus pooled review show fewer HE hospitalizations; evidence base modest in size. Moderate ↑ benefit · moderate 2
Reduced bloating/flatulence in IBSSingle small RCT (n=25) improved bloating but not pain, gas, or urgency. Preliminary ↔ mixed · small 1

Dosing & Compounds

Typical Dose
Pouchitis maintenance: ~900 billion CFU/day (often 1 high-potency sachet daily or 2 packets). Ulcerative colitis: 3.6 trillion CFU/day in trials (e.g., 2 x 900 billion twice daily). Hepatic encephalopathy: 9 x 10^11 (900 billion) bacteria/day. Powder mixed in cold water/food; refrigerated; taken daily, typically split doses with meals.
Active Compounds
De Simone Formulation (current brand: Visbiome / Visbiome Extra Strength)VSL#3 (pre-2016 trials used the original De Simone strains; post-2016 VSL#3 is reformulated)8 strains: L. acidophilus, L. paracasei, L. plantarum, L. delbrueckii subsp. bulgaricus, B. breve, B. longum, B. infantis (B. longum subsp. infantis), S. thermophilusSachet/powder (~450 billion CFU per packet) and capsule forms; high-potency 900-billion-CFU sachets

Safety & Cautions

Generally well tolerated in trials; the most common adverse effect is mild, transient bloating/flatulence. As a high-CFU live-bacteria product, use caution in critically ill patients, those with central venous catheters, severe immunocompromise, or short-gut/severe mucosal barrier disruption, where rare bacteremia/translocation is a theoretical risk. Should be kept refrigerated to preserve viability. Patients should distinguish the original De Simone Formulation (Visbiome) from the post-2016 reformulated VSL#3 when relying on the published trial evidence. Educational only — always check with your doctor or pharmacist before combining De Simone Formulation (VSL#3 / Visbiome) with any medicine.

Key Studies

systematic review Mardini 2014 (Metab Brain Dis review) ✓ Source
Pooled probiotic data (incl. VSL#3) show reduced progression to overt hepatic encephalopathy, odds ratios ~0.22-0.42.
RCT Tursi 2010 (Am J Gastroenterol) ✓ PubMed
Multicenter RCT in mild-moderate UC (n=144): 57.7% reached >=50% UCDAI reduction on VSL#3 vs 39.7% placebo (P=.031); higher remission/mucosal healing.
RCT Dhiman 2014 (Gastroenterology) ✓ PubMed
Double-blind RCT in cirrhosis post-HE: VSL#3 lowered HE hospitalization (19.7% vs 42.2%) and improved CTP/MELD over 6 months.
RCT Mimura 2004 (Gut) ✓ PubMed
In chronic recurrent/refractory pouchitis, remission maintained at 1 year in 85% on VSL#3 (17/20) vs 6% on placebo (1/16).
RCT Gionchetti 2000 (Gastroenterology) ✓ PubMed
Double-blind maintenance trial in chronic pouchitis: 15% relapse on VSL#3 (3/20) vs 100% on placebo (20/20) over 9 months.
RCT Sood 2009 (Clin Gastroenterol Hepatol) ✓ PubMed
RCT in mild-moderate active UC: remission in 42.9% on VSL#3 vs 15.7% placebo at 12 weeks; significant UCDAI improvement.
RCT Kim 2003 (Aliment Pharmacol Ther) ✓ PubMed
RCT in diarrhea-predominant IBS (n=25): VSL#3 significantly reduced abdominal bloating (P=.046) but not pain, gas, or urgency.
RCT Miele 2009 (Am J Gastroenterol) ✓ PubMed
Pediatric UC RCT: VSL#3 induced remission in 92.8% vs 36.4% placebo and reduced relapse during maintenance.
8 sources cited · 8 verified Search all studies on PubMed ↗

Common questions about De Simone Formulation (VSL#3 / Visbiome)

What is De Simone Formulation (VSL#3 / Visbiome) used for?

De Simone Formulation (VSL#3 / Visbiome) is most often taken for Maintains remission in chronic/recurrent pouchitis (best-supported, AGA-guideline-endorsed indication), Induces and maintains remission in mild-to-moderate ulcerative colitis as add-on to standard therapy, Secondary prophylaxis of hepatic encephalopathy in cirrhosis — fewer HE hospitalizations, Reduces liver disease severity and overall hospitalization in cirrhosis. High-dose 8-strain blend with the best gut-microbiome RCT evidence base for pouchitis and ulcerative colitis

Does De Simone Formulation (VSL#3 / Visbiome) work — what does the evidence say?

Strong evidence. Multiple high-quality RCTs / meta-analyses with consistent effects. The De Simone Formulation (originally sold as VSL#3, now as Visbiome) is a high-dose 8-strain blend with the most robust trial evidence of any probiotic in inflammatory bowel conditions. Its best-supported, guideline-endorsed indication is maintaining remission in chronic/recurrent pouchitis, where double-blind RCTs show dramatic relapse reductions versus placebo. High-quality RCTs also support inducing and maintaining remission in mild-to-moderate ulcerative colitis as an adjunct, and secondary prophylaxis of hepatic encephalopathy in cirrhosis. Evidence in IBS is weaker and largely limited to bloating/flatulence. Note: since 2016 the original De Simone strains are sold only as Visbiome; current VSL#3 is a reformulated product, so older trial data apply specifically to this formulation.

What is the typical dose of De Simone Formulation (VSL#3 / Visbiome)?

Pouchitis maintenance: ~900 billion CFU/day (often 1 high-potency sachet daily or 2 packets). Ulcerative colitis: 3.6 trillion CFU/day in trials (e.g., 2 x 900 billion twice daily). Hepatic encephalopathy: 9 x 10^11 (900 billion) bacteria/day. Powder mixed in cold water/food; refrigerated; taken daily, typically split doses with meals.

Is De Simone Formulation (VSL#3 / Visbiome) safe? Any cautions or side effects?

Generally well tolerated in trials; the most common adverse effect is mild, transient bloating/flatulence. As a high-CFU live-bacteria product, use caution in critically ill patients, those with central venous catheters, severe immunocompromise, or short-gut/severe mucosal barrier disruption, where rare bacteremia/translocation is a theoretical risk. Should be kept refrigerated to preserve viability. Patients should distinguish the original De Simone Formulation (Visbiome) from the post-2016 reformulated VSL#3 when relying on the published trial evidence.

How many studies support De Simone Formulation (VSL#3 / Visbiome)?

NutriDex cites 8 sources for De Simone Formulation (VSL#3 / Visbiome), graded "Strong".

Cite this page
APA

Peh, D. (2026). De Simone Formulation (VSL#3 / Visbiome) (8-strain high-dose blend): Benefits, Dosage, Side Effects & Evidence. NutriDex — The Supplement Research Compendium. Retrieved 26 Jun 2026, from https://nutridex.info/s/de-simone-vsl3

BibTeX
@misc{nutridex_de_simone_vsl3,
  author       = {Peh, Daryl},
  title        = {De Simone Formulation (VSL#3 / Visbiome) (8-strain high-dose blend): Benefits, Dosage, Side Effects \& Evidence},
  year         = {2026},
  howpublished = {NutriDex --- The Supplement Research Compendium},
  url          = {https://nutridex.info/s/de-simone-vsl3},
  note         = {Reviewed by Dr Daryl Peh, MBBS Singapore, MMed FM. Accessed 2026-06-26}
}

For medical claims, citing the underlying primary studies linked above is preferred. NutriDex is an educational reference, not medical advice.

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