Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Meta-Analysis
. 2018 Dec;30(12):e13427.
doi: 10.1111/nmo.13427. Epub 2018 Aug 1.

Systematic review and meta-analysis: Efficacy of patented probiotic, VSL#3, in irritable bowel syndrome

M Connell  1 , A Shin  1 , T James-Stevenson  1 , H Xu  2 , T F Imperiale  1 , J Herron  3
Affiliations
Meta-Analysis

Systematic review and meta-analysis: Efficacy of patented probiotic, VSL#3, in irritable bowel syndrome

M Connell et al. Neurogastroenterol Motil. 2018 Dec.

Abstract

Background: VSL#3 is a patented probiotic for which several clinical trials suggest benefits on motor function, bloating, and symptoms of irritable bowel syndrome (IBS).

Objectives: To quantify effects of VSL#3 on abdominal pain, stool consistency, overall response, abdominal bloating, and quality of life (QOL) in IBS through meta-analysis.

Methods: MEDLINE (OvidSP and PubMed), EMBASE, Web of Science, and Scopus were searched up to May 2017. Using a fixed effects model, we pooled data from intention-to-treat analyses of randomized trials (RCTs) comparing VSL#3 to placebo in IBS. Data were reported as relative risk (RR), overall mean difference (MD), or standardized MD (SMD) with 95% confidence intervals (CI). Quality of evidence was rated using the GRADE approach.

Key results: Among 236 citations, 5 RCTs (243 patients) were included. No significant differences were observed for abdominal pain (SMD = -0.03; 95% CI -0.29 to 0.22), bloating (SMD = -0.15; 95% CI -0.40 to 0.11), proportion of bowel movements with normal consistency (overall MD = 0; 95% CI -0.09 to 0.08), or IBS-QOL (SMD = 0.08; 95% CI -0.22 to 0.39). VSL#3 was associated with a nearly statistically significant increase in overall response (RR = 1.39; 95% CI 0.99-1.98).

Conclusions & inferences: In this systematic review and meta-analysis, there was a trend toward improvement in overall response with VSL#3, but no clear evidence effectiveness for IBS. However, the number and sample sizes of the trials are small and the overall quality of evidence for 3 of the 5 outcomes was low. Larger trials evaluating validated endpoints in well-defined IBS patients are warranted.

Keywords: VSL#3; irritable bowel syndrome; probiotic; systematic review.

PubMed Disclaimer

Figures

Figure 1:
Figure 1:
Study selection flow diagram
Figure 2:
Figure 2:
Pooled effects of VSL#3 vs. placebo on abdominal pain reported as standardized mean difference
Figure 3:
Figure 3:
Pooled effects of VSL#3 vs. placebo on stool consistency reported as mean difference
Figure 4:
Figure 4:
Pooled effects of VSL#3 vs. placebo on overall response reported as risk ratio
Figure 5:
Figure 5:
Pooled effects of VSL#3 vs. placebo on abdominal bloating reported as standardized mean difference
Figure 6:
Figure 6:
Pooled effects of VSL# vs. placebo on quality of life scores reported as standardized mean difference
See this image and copyright information in PMC

Comment in

References

    1. Sperber AD, Dumitrascu D, Fukudo S, et al. The global prevalence of IBS in adults remains elusive due to the heterogeneity of studies: a Rome Foundation working team literature review. Gut 2017;66:1075–1082. - PubMed
    1. Mearin F, Lacy BE, Chang L, et al. Bowel Disorders. Gastroenterology 2016. - PubMed
    1. Riviere A, Selak M, Lantin D, et al. Bifidobacteria and Butyrate-Producing Colon Bacteria: Importance and Strategies for Their Stimulation in the Human Gut. Front Microbiol 2016;7:979. - PMC - PubMed
    1. Parkes GC, Brostoff J, Whelan K, et al. Gastrointestinal microbiota in irritable bowel syndrome: their role in its pathogenesis and treatment. Am J Gastroenterol 2008;103:1557–67. - PubMed
    1. Bhattarai Y, Muniz Pedrogo DA, Kashyap PC. Irritable bowel syndrome: a gut microbiota-related disorder? Am J Physiol Gastrointest Liver Physiol 2017;312:G52-G62. - PMC - PubMed

Publication types

LinkOut - more resources