A randomized controlled trial of a probiotic, VSL#3, on gut transit and symptoms in diarrhoea‐predominant irritable bowel syndrome
Open accessAbstract
Summary: Aim : To investigate the effects of a probiotic formulation, VSL#3, on gastrointestinal transit and symptoms of patients with Rome II irritable bowel syndrome with predominant diarrhoea. Methods : Twenty‐five patients with diarrhoea‐predominant irritable bowel syndrome were randomly assigned to receive VSL#3 powder (450 billion lyophilized bacteria/day) or matching placebo twice daily for 8 weeks after a 2‐week run‐in period. Pre‐ and post‐treatment gastrointestinal transit measurements were performed in all patients. Patients recorded their bowel function and symptoms daily in a diary during the 10‐week study, which was powered to detect a 50% change in the primary colonic transit end‐point. Results : There were no significant differences in mean gastrointestinal transit measurements, bowel function scores or satisfactory global symptom relief between the two treatment groups, pre‐ or post‐therapy. Differences in abdominal bloating scores between treatments were borderline significant (P = 0.09, analysis of covariance). Further analysis revealed that abdominal bloating was reduced (P = 0.046) with VSL#3 [mean post‐ minus pre‐treatment score, − 13.7; 95% confidence interval (CI), − 2.5 to − 24.9], but not with placebo (P = 0.54) (mean post‐ minus pre‐treatment score, − 1.7; 95% CI, 7.1 to − 10.4). With the exception of changes in abdominal bloating, VSL#3 had no effect on other individual symptoms: abdominal pain, gas and urgency. All patients tolerated VSL#3 well. Conclusion : VSL#3 appears to be promising in the relief of abdominal bloating in patients with diarrhoea‐predominant irritable bowel syndrome. This is unrelated to an alteration in gastrointestinal or colonic transit.
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A similar alleviating effect on bloating of VSL#3 and Bifidobacterium infantis 35624 has been reported in IBS study populations of 35 and 77 subjects, respectively.
“A similar alleviating effect on bloating of VSL#3, 55 a mixture of 8 probiotics, and of B. infantis 35624 16 has been reported in a study population of IBS subjects (35 and 77 subjects, respectively).”
From Effect of a fermented milk containing <i>Bifidobacterium animalis</i> DN‐173 010 on the health‐related quality of life and symptoms in irritable bowel syndrome in adults in primary care: a multicentre, randomized, double‐blind, controlled trial (2007) · cites this paper as [55]
The Discussion reports that VSL#3 appeared to reduce bloating in diarrhoea-predominant IBS, although the between-group difference was only borderline significant (Other symptom assessments; P = 0.09). The Demographic characteristics section says 25 patients were randomized, not 35. The separately cited B. infantis study and its 77 subjects are not attributed to this source. (LLM, conf=0.90)
Experimental — accuracy not yet measuredTwo studies evaluated overall IBS symptoms as a secondary end point only, and both reported a significant beneficial effect of the specific probiotic treatments in patients with IBS-D.
“Two studies evaluated overall IBS symptoms as a secondary end point only, and both reported a significant beneficial effect of the specific probiotic treatments33–39”
From Systematic review: probiotics in the management of lower gastrointestinal symptoms in clinical practice - an evidence-based international guide (2013) · cites this paper as [38]
Two studies evaluated overall IBS symptoms as a primary end point, with one reporting a significant beneficial effect of the specific probiotic treatment compared with placebo, and one reporting no significant difference.
“Two studies evaluated overall IBS symptoms as a primary end point, with one reporting a significant beneficial effect of the specific probiotic treatment compared with placebo,37 and one reporting no significant difference.38”
From Systematic review: probiotics in the management of lower gastrointestinal symptoms in clinical practice - an evidence-based international guide (2013) · cites this paper as [38]
Probiotic effects on bloating are inconsistent, though certain strains-B. lactis DN-173118, Bifidobacterium animalis DN-173 010, and VSL#3-have shown benefit in some IBS studies.
“Efficacy of probiotic administration for symptoms of bloating have been less consistently reported153 although some studies in IBS patients have suggested benefit with specific probiotic strains including B. lactis DN-173118, Bifidobacterium animalis DN-173 010154, and VSL#3155.”
From The gut Microbiome in adult and pediatric functional gastrointestinal disorders (2019) · cites this paper as [155]
Probiotics increase stool frequency, stool volume or weight, and stool consistency.
“Improvement of stool frequency and/or volume or weight, and stool consistency has been shown (4 -8) .”
Most studies of probiotics on gastrointestinal well-being in the general population investigated bowel habits and used small samples of thirty to eighty subjects.
“Most of these studies have investigated the effect of probiotics on bowel habits and were conducted in small sample sizes (from thirty to eighty subjects).”
Probiotics have been shown to improve bowel habits or transit time in healthy populations.
“The ability of probiotics to improve bowel habits or transit time has been shown in healthy populations.”
Two different multispecies probiotic combinations have shown favourable effects on IBS symptoms: one containing two lactobacilli, one bifidobacteria and one propionic acid bacteria, and another containing eight strains (VSL#3).
“Furthermore, two different multispecies probiotics have shown favourable effects on symptoms of IBS: a combination of two lactobacilli, one bifidobacteria and one propionic acid bacteria, 10 as well as a combination of eight strains, VSL#3. 11, 12”
From Clinical trial: multispecies probiotic supplementation alleviates the symptoms of irritable bowel syndrome and stabilizes intestinal microbiota (2008) · cites this paper as [11]
The effect of probiotics on intestinal motility and transit time in D-IBS is less proven.
“but the effect on intestinal motility and transit time in this subtype of patients is less proven [149]”
From Gut microbiota role in irritable bowel syndrome: New therapeutic strategies (2016) · cites this paper as [149]
Specific probiotics help relieve overall symptom burden in some patients with IBS, with high grade of evidence.
“Specific probiotics help relieve overall symptom burden in some patients with IBS High [147,149,150,152,156-157,169, 174,176-178]”
From Gut microbiota role in irritable bowel syndrome: New therapeutic strategies (2016) · cites this paper as [149]
Specific probiotics help relieve overall symptom burden in some patients with D-IBS, with moderate grade of evidence.
“Specific probiotics help relieve overall symptom burden in some patients with D-IBS Moderate [147,149,174-175]”
From Gut microbiota role in irritable bowel syndrome: New therapeutic strategies (2016) · cites this paper as [149]
Specific probiotics help reduce bloating/distension in some patients with IBS, with moderate grade of evidence.
“Specific probiotics help reduce bloating/distension in some patients with IBS Moderate [147,149-150,155-156,168-170, 174-177,179-183]”
From Gut microbiota role in irritable bowel syndrome: New therapeutic strategies (2016) · cites this paper as [149]
Probiotics tested to date do not help reduce flatus in patients with IBS, with low grade of evidence.
“Probiotics tested to date do not help reduce flatus in patients with IBS Low [147,149-150,156,168,174-175, 178-179,184]”
From Gut microbiota role in irritable bowel syndrome: New therapeutic strategies (2016) · cites this paper as [149]
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- Authors
- Kim, H. J., Camilleri, M., Mckinzie, S., Lempke, M. B., Burton, D. D., Thomforde, G. M., & Zinsmeister, A. R.
- Affiliations
- Mayo Clinic (US)
- Corresponding author
- Camilleri, M.
- Venue
- Alimentary Pharmacology & Therapeutics
- Publisher
- Wiley
- Published
- 2003-03-26
- Volume
- 17
- Issue
- 7
- Pages
- 895-904
- ISSN
- 0269-2813 (ISSN-L)
- 1365-2036
- OpenAlex
- W2010235735
- Semantic Scholar
- 47c4d6a099c66bfc14679f4742ae28df73cc8563
- Cited by
- 468
- References
- 37
- Citations by year
- 2026: 2 · 2025: 1 · 2024: 7 · 2023: 8 · 2022: 8 · 2021: 8 · 2020: 11 · 2019: 10 · 2018: 24 · 2017: 20 · 2016: 20 · 2015: 18 · 2014: 29 · 2013: 20 · 2012: 35
- FWCI
- 28.43
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Alimentary Pharmacology & Therapeutics (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institutes of Health (R01‐grant, RR-00585)
- National Institute of Diabetes and Digestive and Kidney Diseases (R01 DK-54681, R01DK054681)
- National Center for Research Resources (RR-00585, M01RR000585)
- Topics
- Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
- Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
- Keywords
- VSL#3, probiotics, diarrhea-predominant irritable bowel syndrome, gastrointestinal transit, colonic transit, bloating, bowel function, symptom relief, abdominal pain, gases, bowel urgency
- MeSH terms
- Adolescent, Adult, Aged, Colonic Diseases, Functional, Diarrhea, Double-Blind Method, Female, Gastrointestinal Transit, Humans, Male, Middle Aged, Patient Compliance, Treatment Outcome, Probiotics
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