We use essential cookies (authentication, your saved goals/stack) by default. With your permission we’ll also enable privacy-respecting analytics (Vercel Web Analytics, anonymous load-time metrics) and error-replay diagnostics (Sentry — DOM snapshots only when an error fires) so we can fix bugs faster. Learn more about cookies
Vsl6.5
VSL#3 / Visbiome Research
Mostly mechanism / observational
20 peer-reviewed studies
What the evidence says
Mostly mechanism / observational
Most VSL#3 / Visbiome studies are mechanism or observational rather than RCTs that measure a clinical effect — keep findings provisional.
Most evidence is from high-quality meta-analyses and randomised trials published 2000–2023 with a typical study size of 71 participants.
Based on 20 studies · 6 meta-analyses · 10 RCTs · 1,642 total participants
Confidence
High confidence
By outcome
Ulcerative colitis
Mostly mechanism / observational11 studies
Pouchitis
Mostly mechanism / observational7 studies
Safety profile
Mostly mechanism / observational6 studies
Crohn's disease
Mostly mechanism / observational5 studies
IBS & general digestive symptomsStrong benefit specifically for pouchitis after ulcerative colitis surgery and modest benefit for active ulcerative colitis. No demonstrated benefit for IBS or general digestive comfort · 8-12 weeks
Mostly mechanism / observational5 studies
Liver disease & hepatic encephalopathy
Too few graded studies1 study
InflammationDirectly reduces mucosal inflammatory cytokines and helps induce remission in active ulcerative colitis as an add-on to standard therapy · 8-12 weeks
Too few graded studies1 study
Therapeutic & clinical
Too few graded studies1 study
Steady research
4 studies in the last 5 years · Latest meta-analysis: 2023
200020112023
1Meta-Analysis2019
In plain English: Cochrane found 85% of participants maintained pouchitis remission versus 3% on placebo, while grading the evidence low certainty and reporting results under the name De Simone Formulation rather than a brand.
Nguyen N et al. · Cochrane Database Syst Rev (2019)
Chronic pouchitis maintenance: 85% (34/40) maintained remission at 9-12 months vs 3% (1/36) placebo — RR 20.24 (95% CI 4.28-95.81), low certainty
Prevention: 90% (18/20) had no acute pouchitis at 12 months vs 60% (12/20) placebo — RR 1.50 (1.02-2.21), low certainty
In plain English: Probiotics as a class showed no benefit for active ulcerative colitis, but restricting the analysis to this blend produced a significant effect — and nothing worked in Crohn's disease.
Derwa Y et al. · Aliment Pharmacol Ther (2017)
Probiotics as a class: no benefit for inducing remission in active UC, RR of failure 0.86 (0.68-1.08)
Restricted to this blend: RR of failure 0.74 (0.63-0.87)
Probiotics roughly equivalent to 5-ASA for preventing UC relapse: RR 1.02 (0.85-1.23)
In plain English: The post-operative Crohn's trial missed its primary endpoint at day 90, though mucosal inflammatory cytokines were reduced.
Fedorak RN et al. · Clin Gastroenterol Hepatol (2015)
PRIMARY ENDPOINT MISSED: severe endoscopic lesions at day 90 in 9.3% on the probiotic vs 15.7% placebo (P=.19)
Among patients with non-severe lesions at day 90, severe endoscopic recurrence at day 365 was 10.0% on early treatment vs 26.7% on late treatment (P=.09) — also not significant
Aggregate severe recurrence rates 20.5% (early) vs 42.1% (late) were not statistically different
In plain English: The dedicated IBS meta-analysis found no effect on pain, bloating, stool consistency or quality of life, with only a non-significant trend toward improved overall response.
Connell M et al. · Neurogastroenterol Motil (2018)
Abdominal pain SMD -0.03 (95% CI -0.29 to 0.22) — no effect
Bloating SMD -0.15 (-0.40 to 0.11); normal stool consistency MD 0 (-0.09 to 0.08)
In plain English: In this trial with no control group, a decrease in depressive symptoms in healthy older volunteers was observed after a 2-month healthy diet intervention, independently of inflammation but with possible limitations due to participation.
Bourdel-Marchasson I et al. · Nutrients (2020)
A decrease of CES-D score was seen in the four arms (A: -40.0%, p = 0.001; B: -32.5%, p = 0.023; C: -42.8%, p = 0.004; and D: -33.3%, p = 0.21).
Within the subgroups of subjects with medium/high inflammation a similar decrease in CES-D score occurred in all groups (A: -44.8%, p = 0.021; B, -46.7%, p = 0.024; C, -52.2%, p = 0.039; D, -43.8%, p = 0.037).
The effect of interventions on CES-D was not related to baseline inflammation.
In plain English: Added to standard therapy it reduced disease activity scores, but the authors' own conclusion states that the rectal bleeding and remission findings do not reach statistical significance.
Tursi A et al. · Am J Gastroenterol (2010)
At least 50% disease activity decrease: 63.1% vs 40.8% (per protocol P=0.010; intention to treat P=0.031)
Improvement of 3 or more points in the UCDAI score: 60.5% vs 41.4% (per protocol P=0.017; intention to treat P=0.046)
Rectal bleeding: per protocol P=0.014 and intention to treat P=0.036 in the results table — BUT the authors' stated conclusion is that VSL#3 'improves rectal bleeding and seems to reinduce remission ... although these parameters do not reach statistical significance'
In plain English: The primary endpoint of preventing breakthrough hepatic encephalopathy was missed, though hospitalisations and liver scores improved.
In plain English: This blend beat placebo for both clinical remission and clinical response in active ulcerative colitis, and was statistically indistinguishable from faecal microbiota transplantation.
Dang X et al. · PLoS One (2020)
VSL#3 vs placebo for clinical remission: OR 2.40 (95% CI 1.49-3.88); clinical response OR 3.09 (95% CI 1.53-6.25)
Faecal microbiota transplantation vs placebo: remission OR 3.47 (1.93-6.25); response OR 2.48 (1.18-5.21)
Indirect comparison between FMT and VSL#3 was not significant for remission (RR 1.20, 0.70-2.06) or response (RR 0.95, 0.62-1.45)
In plain English: Blood immune activation markers in immunologic nonresponder individuals on effective antiretroviral treatment were not reduced by supplementation with DSFP; CD4+ T-cell activation may have been increased.
Rousseau RK et al. · Journal of acquired immune deficiency syndromes (1999) (2022)
Blood CD8 activation increased 0.82 percentage points (pp) in the probiotic arm (95% confidence interval: -1.23 to 2.87;) and decreased by 2.06 pp in the placebo arm (-4.81 to 0.70; between arms P = 0.097).
CD4+ T-cell activation (%HLA-DR+) decreased in the placebo arm [-3.79 pp (-7.32 to -0.26)] but increased in the probiotic arm [1.64 (-0.98 to 4.26); between arms P = 0.018].
Blood immune activation markers in immunologic nonresponder individuals on effective antiretroviral treatment were not reduced by supplementation with DSFP; CD4+ T-cell activation may have been increased.
Naseer M et al. · Current clinical pharmacology (2020)
The efficacy of prebiotics such as fructooligosaccharides and Plantago ovata seeds in ulcerative colitis are inconclusive and the data regarding the utility of prebiotics in pouchitis is limited.
The results of the clinical trials for remission induction and maintenance in active Crohn's disease or post-operative relapse with probiotics and prebiotics are inadequate and not very convincing.
Prebiotics and probiotics are safe, effective and have great therapeutic potential.
In plain English: Moreover, we suggest the need to search for more therapeutic possibilities, especially via the research and application of synbiotics and postbiotics.
Wei L et al. · European journal of pharmacology (2022)
The anti-cancer effect of individual probiotics has been extensively studied, and the exact curative effect of various probiotics has been found, but the anti-cancer effect of mixed probiotics is still not well summarized.
In this review, we discuss the positive effects of mixed probiotics on CRC and the related mechanisms of action, especially VSL#3 (VSL Pharmaceuticals, Inc., Gaithersburg, MD, USA), thus providing new ideas for the treatment of CRC.
Moreover, we suggest the need to search for more therapeutic possibilities, especially via the research and application of synbiotics and postbiotics.
In plain English: This study suggested that the adherence to probiotic therapy is affected by different factors in patients with IBS in a real-life setting.
Laterza L et al. · Minerva medica (2023)
Sixty percent of patients took all the prescribed probiotic therapy in real-life setting, with perceived benefits in more than 60% of cases.
Among the 20 patients with reduced adherence, 5 took less than 50%, 12 took 50% and 2 took more than 50% but less than 80% of the prescribed doses.
This study suggested that the adherence to probiotic therapy is affected by different factors in patients with IBS in a real-life setting.
In plain English: The guideline's published erratum states that its recommendation refers only to the product used in the cited literature, now known generically as the De Simone Formulation.
Sood A et al. · Indian J Gastroenterol (2019)
A formal published erratum to the Asian Working Group guidelines on diet and inflammatory bowel disease
States that the recommendations which recommend 'VSL#3' refer only to the product used in the cited literature and equivalent products, independent of present product labelling
States that this product is now known by the generic name 'De Simone Formulation'