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.
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.
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 9 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 16 Sept 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 2026-09-16}
}
For medical claims, citing the underlying primary studies linked above is preferred. NutriDex is an educational reference, not medical advice.