Research
VSL#3 (High-Potency Probiotic)
62 peer-reviewed studies curated from PubMed and Semantic Scholar.
Studies
Sorted by quality and recency
The safety profile of probiotic VSL#3®. A meta-analysis of safety data from double-blind, randomized, placebo-controlled clinical trials.
Meta-analysis of safety data from three double-blind, randomized, placebo-controlled trials and one observational trial on the probiotic VSL#3®. The analysis included 120 patients, with no significant difference in adverse events between VSL#3® and placebo, except for a favorable outcome in injury, poisoning, and procedural complications for VSL#3®. VSL#3® is concluded to be safe and well-tolerated.
Assessing the efficacy and safety of fecal microbiota transplantation and probiotic VSL#3 for active ulcerative colitis: A systematic review and meta-analysis.
Systematic review and meta-analysis comparing fecal microbiota transplantation and probiotic VSL#3 for active ulcerative colitis. Both treatments were superior to placebo in clinical remission and response, with no significant increase in adverse events. No statistical difference was found between the two treatments.
Systematic review and meta-analysis: Efficacy of patented probiotic, VSL#3, in irritable bowel syndrome.
Systematic review and meta-analysis of 5 RCTs with 243 patients evaluating the efficacy of VSL#3 in irritable bowel syndrome (IBS). No significant differences were observed for abdominal pain, bloating, stool consistency, or quality of life. There was a trend toward improvement in overall response, but no clear evidence of effectiveness for IBS.
Role of probiotics VSL#3 in prevention of suspected sepsis in low birthweight infants in India: a randomised controlled trial.
RCT in rural India assessing the effect of probiotic VSL#3 on preventing neonatal sepsis in low birthweight infants. The study found a non-significant 21% reduction in risk of neonatal sepsis and reduced median days of hospitalisation in the probiotics group.
Treatment and prevention of pouchitis after ileal pouch-anal anastomosis for chronic ulcerative colitis.
Systematic review of 13 studies with 517 participants assessing medical therapies for pouchitis after ileal pouch-anal anastomosis. Low quality evidence suggests VSL#3 may be more effective than placebo for maintenance of remission and prevention of pouchitis.
Effect of probiotics on inducing remission and maintaining therapy in ulcerative colitis, Crohn's disease, and pouchitis: meta-analysis of randomized controlled trials.
Meta-analysis of 23 RCTs with 1763 participants comparing probiotics to controls in inflammatory bowel disease. Probiotics, particularly VSL#3, significantly increased remission rates in active ulcerative colitis and reduced relapse rates in pouchitis. No significant adverse events were found compared to controls.
Probiotic mix VSL#3 is effective adjunctive therapy for mild to moderately active ulcerative colitis: a meta-analysis.
Meta-analysis of five studies with 441 patients evaluating the efficacy of VSL#3 as adjunctive therapy for mild to moderately active ulcerative colitis. VSL#3 showed higher response and remission rates compared to placebo, with no serious side effects reported.
Survival and cancer recurrence after short-course perioperative probiotics in a randomized trial.
RCT with 6-year follow-up of surgical patients evaluating short-course perioperative oral probiotic VSL#3 versus placebo. The study found no significant difference in overall or progression-free survival between the probiotic and placebo groups after complex surgery for visceral malignancy.
Systematic review with meta-analysis: the efficacy of probiotics in inflammatory bowel disease.
Systematic review and meta-analysis of 22 RCTs examining the efficacy of probiotics in inflammatory bowel disease (IBD). VSL#3 may be effective in inducing remission in active ulcerative colitis (UC), while probiotics may be as effective as 5-ASAs in preventing relapse of quiescent UC. No benefit was found for Crohn's disease (CD).
Probiotic VSL#3 prevents antibiotic-associated diarrhoea in a double-blind, randomized, placebo-controlled clinical trial.
This double-blind, randomized, placebo-controlled trial investigated the effect of the probiotic VSL#3 on preventing antibiotic-associated diarrhoea (AAD) in hospital inpatients. The study found a significant reduction in AAD incidence in the active group compared to placebo, although no cases of Clostridium difficile-associated diarrhoea (CDAD) were detected.
Cost-effectiveness analysis of adjunct VSL#3 therapy versus standard medical therapy in pediatric ulcerative colitis.
Systematic review and Markov model analysis comparing standard medical therapy to medical therapy plus VSL#3 in pediatric ulcerative colitis. The study found that adjunct VSL#3 therapy is not cost-effective with an ICER of $79,910 per QALY gained, though certain parameters could make it cost-effective.
Treatment and prevention of pouchitis after ileal pouch-anal anastomosis for chronic ulcerative colitis.
Meta-analysis of 11 RCTs assessing the efficacy of various agents for treating and preventing pouchitis after ileal pouch-anal anastomosis for ulcerative colitis. VSL#3 was found to be more effective than placebo in maintaining remission of chronic pouchitis and in some cases for prevention, while ciprofloxacin was more effective than metronidazole for acute pouchitis.
Use of probiotics for prevention of radiation-induced diarrhea.
Double-blind, placebo-controlled trial of 490 cancer patients undergoing radiation therapy, testing the efficacy of the probiotic preparation VSL#3 in preventing radiation-induced diarrhea. VSL#3 significantly reduced the incidence and severity of diarrhea compared to placebo.
A randomised placebo controlled trial of VSL#3probiotic on biomarkers of cardiovascular risk and liver injury in non-alcoholic fatty liver disease.
RCT of VSL#3 probiotic supplementation in 35 patients with NAFLD to assess effects on cardiovascular risk and liver injury biomarkers. No significant improvements were observed in these biomarkers following supplementation.
Long-Term Effects of a Web-Based Low-FODMAP Diet Versus Probiotic Treatment for Irritable Bowel Syndrome, Including Shotgun Analyses of Microbiota: Randomized, Double-Crossover Clinical Trial.
This randomized, double-crossover clinical trial compared the long-term effects of a web-based low-FODMAP diet and probiotic treatment (VSL#3) on IBS symptoms. Both interventions were equally effective in managing IBS symptoms, but responses could not be predicted by microbiota composition. The study involved 34 IBS patients and 6 healthy controls, with 180 fecal samples analyzed for microbiota composition.
A proof of concept pilot trial of probiotics in symptomatic oral lichen planus (CABRIO).
A randomized double-blind pilot trial of probiotic VSL#3 versus placebo in 30 individuals with symptomatic oral lichen planus. The study found no statistically significant changes in pain, disease activity, quality of life, or oral microbial composition, though there was a trend towards reduced salivary IFN-γ levels in the probiotic group.
Randomized Trial of Perioperative Probiotics Among Patients Undergoing Major Abdominal Operation.
This double-blind randomized trial investigated the effects of perioperative oral probiotic VSL#3 on patients undergoing major gastrointestinal operations. The study found no significant difference in the 30-day composite end point of mortality, readmission, and infection rate between the probiotic and placebo groups. However, a higher readmission rate was observed in the probiotic group, with some cases due to dehydration related to diet intolerance and/or diarrhea.
Investigation of probiotics in multiple sclerosis.
Pilot study investigating the effect of VSL3 probiotics on the gut microbiome and peripheral immune system function in healthy controls and MS patients. VSL3 administration increased abundance of Lactobacillus, Streptococcus, and Bifidobacterium species and induced an anti-inflammatory immune response.
A phase II study (ARCHER 1042) to evaluate prophylactic treatment of dacomitinib-induced dermatologic and gastrointestinal adverse events in advanced non-small-cell lung cancer.
Phase II RCT evaluating prophylactic treatments for dacomitinib-induced adverse events in advanced NSCLC patients. Doxycycline reduced grade ≥2 SDAEI incidence and improved QoL. Alclometasone improved QoL but did not significantly reduce SDAEI incidence. VSL#3 probiotic did not reduce diarrhea or mucositis incidence.
Administration of a multistrain probiotic product (VSL#3) to women in the perinatal period differentially affects breast milk beneficial microbiota in relation to mode of delivery.
Double-blind, placebo-controlled RCT of 66 women evaluating the effect of VSL#3 probiotic supplementation during late pregnancy and lactation on breast milk microbiota. Probiotic supplementation increased lactobacilli and bifidobacteria levels in breast milk of vaginally delivering women, but not in those with caesarean section.
Probiotic VSL#3 reduces liver disease severity and hospitalization in patients with cirrhosis: a randomized, controlled trial.
RCT assessing the efficacy of probiotic VSL#3 in patients with cirrhosis and hepatic encephalopathy. VSL#3 reduced the risk of hospitalization for HE and improved liver disease severity scores over 6 months compared to placebo.
The probiotic VSL#3 has anti-inflammatory effects and could reduce endoscopic recurrence after surgery for Crohn's disease.
This multicenter, randomized, double-blind, placebo-controlled trial investigated the probiotic VSL#3 for preventing Crohn's disease recurrence after surgery. While there were no statistical differences in endoscopic recurrence rates at day 90 between VSL#3 and placebo, VSL#3 reduced mucosal inflammatory cytokine levels and showed a lower rate of recurrence among patients who received it for the entire 365 days.
Chronic bacterial prostatitis and irritable bowel syndrome: effectiveness of treatment with rifaximin followed by the probiotic VSL#3.
RCT evaluating the effect of rifaximin followed by the probiotic VSL#3 on chronic prostatitis progression in 95 infertile male patients with bacteriologically cured chronic bacterial prostatitis and IBS. Long-term treatment with rifaximin and VSL#3 reduced the progression of prostatitis into more complicated forms of male accessory gland infections.
Impact of personalized diet and probiotic supplementation on inflammation, nutritional parameters and intestinal microbiota - The "RISTOMED project": Randomized controlled trial in healthy older people.
RCT assessing the impact of a personalized diet with or without VSL#3 on inflammation, nutrition, and intestinal microbiota in 62 healthy older adults. VSL#3 supplementation improved folate, vitamin B12, and homocysteine levels, and increased bifidobacteria in participants with low-grade inflammation.
Effect of Probiotic (VSL#3) and Omega-3 on Lipid Profile, Insulin Sensitivity, Inflammatory Markers, and Gut Colonization in Overweight Adults: A Randomized, Controlled Trial
RCT in 60 overweight adults evaluating the effects of probiotic VSL#3 and omega-3 fatty acid on insulin sensitivity, blood lipids, and inflammation. VSL#3 significantly reduced cholesterol, triglycerides, LDL, and VLDL, increased HDL, improved insulin sensitivity, decreased hsCRP, and positively affected gut microbiota. Omega-3 improved insulin sensitivity and hsCRP but did not affect gut microbiota. Combined supplementation had more pronounced effects on HDL, insulin sensitivity, and hsCRP.
Effects of the adjunctive probiotic VSL#3 on portal haemodynamics in patients with cirrhosis and large varices: a randomized trial.
Randomized double-blind placebo-controlled trial in 94 cirrhotic patients with large oesophageal varices. Patients received propranolol plus placebo, antibiotics, or probiotic VSL#3. Adjunctive probiotics increased the response rate compared to propranolol alone and were associated with greater decreases in TNF-α levels, suggesting improved portal haemodynamics and inflammation.
Clinical trial assessing VSL#3 for the treatment of anterior resection syndrome.
RCT assessing the efficacy of the probiotic VSL#3 in improving bowel function following ileostomy closure in 63 patients. The study found no statistically significant difference in bowel function or quality of life between the probiotic and placebo groups.
Dietary supplementation with probiotics during late pregnancy: outcome on vaginal microbiota and cytokine secretion.
RCT studying the impact of dietary supplementation with the probiotic VSL#3 on vaginal microbiota and cytokine secretion in healthy women during late pregnancy. The probiotic was associated with modulation of the vaginal microbiota and cytokine secretion, suggesting potential anti-inflammatory effects and implications in preventing preterm birth.
Treatment of relapsing mild-to-moderate ulcerative colitis with the probiotic VSL#3 as adjunctive to a standard pharmaceutical treatment: a double-blind, randomized, placebo-controlled study.
Double-blind, randomized, placebo-controlled study assessing the effects of VSL#3 supplementation in 144 patients with relapsing mild-to-moderate ulcerative colitis already under treatment with 5-ASA and/or immunosuppressants. VSL#3 significantly reduced ulcerative colitis disease activity index scores and improved rectal bleeding compared to placebo, although some parameters did not reach statistical significance.
VSL#3 improves symptoms in children with irritable bowel syndrome: a multicenter, randomized, placebo-controlled, double-blind, crossover study.
Multicenter, randomized, placebo-controlled, double-blind, crossover study of VSL#3 in children with irritable bowel syndrome. VSL#3 significantly improved symptoms such as abdominal pain, bloating, and family assessment of life disruption compared to placebo, with no adverse effects recorded.
The probiotic preparation, VSL#3 induces remission in patients with mild-to-moderately active ulcerative colitis.
Multicenter, randomized, double-blind, placebo-controlled trial of VSL#3 in 147 patients with mild-to-moderately active ulcerative colitis. VSL#3 significantly improved UCDAI scores and induced remission compared to placebo over 12 weeks.
Bacterial and fungal microbiota in relation to probiotic therapy (VSL#3) in pouchitis.
This study explores the role of bacterial and fungal flora in maintaining remission in pouchitis patients using the probiotic VSL#3. The study found that VSL#3 increased bacterial diversity and reduced fungal diversity, suggesting a potential mechanism for maintaining remission in inflammatory barrier diseases of the lower gastrointestinal tract.
Beclomethasone dipropionate plus VSL#3 for the treatment of mild to moderate diverticular colitis: an open, pilot study.
The study investigates the combination of beclomethasone dipropionate and VSL#3 for treating mild to moderate diverticular colitis. It is an open, pilot study.
Low-dose balsalazide plus a high-potency probiotic preparation is more effective than balsalazide alone or mesalazine in the treatment of acute mild-to-moderate ulcerative colitis.
RCT comparing low-dose balsalazide plus VSL#3 probiotic to balsalazide alone and mesalazine in 90 patients with mild-to-moderate ulcerative colitis over 8 weeks. The combination was more effective in achieving remission and was better tolerated than mesalazine.
Prevention of radiation-induced diarrhea with the use of VSL#3, a new high-potency probiotic preparation.
The study investigates the use of VSL#3, a high-potency probiotic preparation, for the prevention of radiation-induced diarrhea.
Probiotic supplementation increases obesity with no detectable effects on liver fat or gut microbiota in obese Hispanic adolescents: a 16-week, randomized, placebo-controlled trial.
A 16-week randomized placebo-controlled trial in 19 obese Latino adolescents examined the effects of VSL#3 probiotic supplementation. The study found significant increases in total and trunk adiposity in the VSL#3 group compared to placebo, with no significant effects on liver fat, gut microbiota, or gut hormones.
Urinary (1)H-NMR-based metabolic profiling of children with NAFLD undergoing VSL#3 treatment.
This study analyzed urinary metabolic profiles of 31 pediatric NAFLD patients undergoing VSL#3 treatment using high-resolution proton nuclear magnetic resonance spectroscopy. VSL#3 treatment induced changes in urinary metabolic phenotype, affecting amino-acid metabolism and correlating with clinical trial endpoints, suggesting non-invasive biomarkers for treatment response.
Probiotic supplementation attenuates increases in body mass and fat mass during high-fat diet in healthy young adults.
RCT of 20 non-obese males examining the effects of VSL#3 probiotic supplementation during a high-fat diet. VSL#3 group showed less increase in body mass and fat mass compared to placebo, but no significant changes in insulin sensitivity or skeletal muscle substrate oxidation.
Probiotic supplementation and trimethylamine-N-oxide production following a high-fat diet.
RCT testing the effect of the multi-strain probiotic VSL#3 on plasma TMAO levels following a high-fat diet in 19 healthy, non-obese males. Plasma TMAO increased significantly in both VSL#3 and placebo groups, with no significant difference between them. VSL#3 did not influence plasma TMAO concentrations.
Randomised clinical trial: The beneficial effects of VSL#3 in obese children with non-alcoholic steatohepatitis.
Double-blind RCT of VSL#3 vs. placebo in 44 obese children with biopsy-proven NAFLD. VSL#3 significantly improved fatty liver severity and increased GLP-1 levels compared to placebo over 4 months.
Oral probiotic VSL#3 attenuates the circulatory disturbances of patients with cirrhosis and ascites.
RCT evaluating the effects of the probiotic VSL#3 on hepatic and systemic haemodynamics in 17 patients with cirrhosis and ascites. VSL#3 administration resulted in reductions of hepatic venous pressure gradient, cardiac index, and heart rate, and increases in systemic vascular resistance and mean arterial pressure. Serum sodium levels increased in most patients.
VSL#3 ® probiotic therapy does not reduce portal pressures in patients with decompensated cirrhosis.
RCT evaluating the effect of the probiotic VSL#3 on hepatic venous pressure gradient (HVPG) in 17 patients with decompensated cirrhosis. The treatment arm showed a greater decrease in HVPG than the placebo arm, but the reduction was not statistically significant. VSL#3 therapy did not significantly impact portal pressure reduction.
Decrease in frequency of liquid stool in enterally fed critically ill patients given the multispecies probiotic VSL#3: a pilot trial.
A single-center, double-blind, randomized, placebo-controlled pilot study evaluated the efficacy of the multispecies probiotic VSL#3 in reducing liquid stool frequency in enterally fed critically ill patients. The intervention group showed a significant reduction in the frequency of liquid stools compared to the control group.
Clinical trial: the effects of a probiotic mixture on non-steroidal anti-inflammatory drug enteropathy - a randomized, double-blind, cross-over, placebo-controlled study.
A double-blind, cross-over trial with 20 healthy volunteers evaluated the effect of a probiotic mixture (VSL#3) compared to placebo on faecal calprotectin concentrations during indomethacin administration. VSL#3 significantly reduced intestinal inflammation compared to placebo, suggesting its potential in decreasing indomethacin-induced intestinal inflammation.
Immunosuppressive effects via human intestinal dendritic cells of probiotic bacteria and steroids in the treatment of acute ulcerative colitis.
RCT evaluating the effects of oral VSL#3 and corticosteroids on colonic dendritic cells in patients with acute ulcerative colitis. VSL#3 treatment decreased TLR-2 expression, increased IL-10 production, and decreased IL-12p40 production, with 10 out of 14 patients showing a clinical response.
Effect of a probiotic preparation (VSL#3) on induction and maintenance of remission in children with ulcerative colitis.
This randomized, placebo-controlled trial assessed the efficacy and safety of the probiotic preparation VSL#3 in children with active ulcerative colitis. VSL#3 significantly improved remission rates and reduced relapse compared to placebo, with no adverse events related to the probiotic.
Effects of probiotic therapy on portal pressure in patients with cirrhosis: a pilot study.
Pilot study of 8 patients with compensated or early decompensated cirrhosis receiving VSL#3 probiotic therapy for 2 months. No change in portal pressure or intestinal permeability was observed, but there was a trend towards reduced plasma endotoxin and a significant reduction in plasma aldosterone. Serum TNF-alpha increased slightly.
Probiotic administration in patients with ileal pouch-anal anastomosis for ulcerative colitis is associated with expansion of mucosal regulatory cells.
Open-label study of 31 patients with ileal pouch-anal anastomosis for ulcerative colitis, randomized to VSL#3 or no treatment for 12 months. VSL#3-treated patients showed a significant reduction in pouchitis disease activity index and an increase in mucosal regulatory T cells.
Balsalazide and/or high-potency probiotic mixture (VSL#3) in maintaining remission after attack of acute, uncomplicated diverticulitis of the colon.
Pilot RCT of 30 patients with uncomplicated diverticulitis comparing balsalazide plus VSL#3 to VSL#3 alone for maintaining remission. Combination treatment was found better than probiotic alone in preventing relapse, though not statistically significant.
High-dose probiotics for the treatment of active pouchitis.
RCT evaluating the efficacy of high-dose VSL#3 probiotics in treating mild pouchitis in 23 patients. 69% of patients achieved remission, with significant improvements in Pouchitis Disease Activity Index and quality of life scores. Remission was maintained during maintenance treatment.
A randomized controlled trial of a probiotic combination VSL# 3 and placebo in irritable bowel syndrome with bloating.
RCT evaluating the effects of the probiotic combination VSL# 3 on symptoms and colonic transit in 48 IBS patients with bloating. VSL# 3 reduced flatulence scores and retarded colonic transit but did not significantly alter bowel function.
VSL#3 probiotic-mixture induces remission in patients with active ulcerative colitis.
RCT evaluating the safety and efficacy of VSL#3 in 34 patients with active mild to moderate ulcerative colitis. VSL#3 treatment resulted in a 77% combined induction of remission/response rate with no adverse events.
Once daily high dose probiotic therapy (VSL#3) for maintaining remission in recurrent or refractory pouchitis.
RCT evaluating the effectiveness of high dose probiotic VSL#3 in maintaining remission in patients with recurrent or refractory pouchitis. Remission was maintained in 85% of patients on VSL#3 compared to 6% on placebo over one year, with associated high quality of life.
Failure to improve parameters of lactose maldigestion using the multiprobiotic product VSL3 in lactose maldigesters: a pilot study.
Pilot study testing the effect of the probiotic VSL3 on lactose maldigestion in two groups of five subjects. Subjects were fed VSL3 before and after a 17-day period, with a lactose challenge conducted before and after. No statistically significant changes in lactose digestion parameters were observed.
Prophylaxis of pouchitis onset with probiotic therapy: a double-blind, placebo-controlled trial.
RCT comparing VSL#3 probiotic therapy to placebo in 40 patients post-ileal pouch-anal anastomosis for ulcerative colitis. VSL#3 significantly reduced the incidence of acute pouchitis and improved quality of life scores.
A randomized controlled trial of a probiotic, VSL#3, on gut transit and symptoms in diarrhoea-predominant irritable bowel syndrome.
RCT of 25 patients with diarrhoea-predominant irritable bowel syndrome comparing VSL#3 probiotic to placebo over 8 weeks. VSL#3 reduced abdominal bloating but had no significant effect on gastrointestinal transit or other symptoms.
Oral bacteriotherapy as maintenance treatment in patients with chronic pouchitis: a double-blind, placebo-controlled trial.
RCT evaluating the efficacy of the probiotic preparation VSL#3 in maintaining remission of chronic pouchitis in 40 patients. The VSL#3 group had significantly fewer relapses compared to placebo, and fecal concentrations of beneficial bacteria increased significantly.
Impact on the composition of the faecal flora by a new probiotic preparation: preliminary data on maintenance treatment of patients with ulcerative colitis.
RCT evaluating the effects of a new probiotic preparation (VSL#3) on intestinal microflora and clinical efficacy in 20 ulcerative colitis patients intolerant to 5-ASA. The probiotic increased faecal concentrations of beneficial bacteria and maintained remission in 15 of 20 patients over 12 months.
Efficacy and Safety of a Multistrain Probiotic Formulation Depends from Manufacturing
The study compared the properties of US-made and Italian-made VSL#3 probiotic formulations in HIV-infected subjects. After 6 months, the US-made formulation showed increased specific bacterial genera and reduced immune activation. Differences in DHA metabolism were observed between the formulations, with implications for efficacy and safety.
Beneficial Metabolic Effects of a Probiotic via Butyrate-induced GLP-1 Hormone Secretion*
The study demonstrates that the probiotic VSL#3 prevents and treats obesity and diabetes in mouse models by inducing butyrate and GLP-1. VSL#3 modulates gut flora, suppresses body weight gain, and improves glucose tolerance, suggesting its potential as a therapeutic option for obesity and diabetes.
Maintenance therapy with a probiotic in antibiotic-dependent pouchitis: experience in clinical practice.
The study evaluated the compliance and efficacy of VSL #3 probiotic treatment in 31 patients with antibiotic-dependent pouchitis. After an initial ciprofloxacin treatment, patients received VSL #3 for 8 months. Only six patients completed the course, with no significant change in Pouchitis Disease Activity Index scores, indicating limited efficacy in maintaining remission.
Probiotics (VSL#3) in arthralgia in patients with ulcerative colitis and Crohn's disease: a pilot study.
Pilot study assessing the safety and efficacy of probiotics (VSL#3) in patients with quiescent IBD suffering from arthralgia. Sixteen of 29 patients completed the trial, with 10 showing significant improvement in joint pain. No relapse of intestinal disease was observed, suggesting VSL#3 may be an alternative treatment for arthralgia in IBD patients.