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Gut Microbiota is Not Modified by Randomized, Double-Blind, Placebo-Controlled Trial of VSL#3 in Diarrhea-Predominant Irritable Bowel Syndrome

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Abstract

Irritable bowel syndrome (IBS) is a common condition that negatively impacts the quality of life for many individuals. The exact etiology of this disorder is largely unknown; however, emerging studies suggest that the gut microbiota is a contributing factor. Several clinical trials show that probiotics, such as VSL#3, can have a favorable effect on IBS. This double-blind, randomized placebo-controlled study has been conducted in diarrhea-predominant IBS subjects in order to investigate the effect of VSL#3 on the fecal microbiota. The bacterial composition of the fecal microbiota was investigated using high-throughput microarray technology to detect 16S RNA. Twenty-four subjects were randomized to receive VSL#3 or placebo for 8 weeks. IBS symptoms were monitored using GSRS and quality-of-life questionnaires. A favorable change in Satiety subscale was noted in the VSL #3 groups. However, the consumption of the probiotic did not change the gut microbiota. There were no adverse events or any safety concerns encountered during this study. To summarize, the use of VSL#3 in this pilot study was safe and showed improvement in specific GSRS-IBS scores in diarrhea-predominant IBS subjects. The gut microbiota was not affected by VSL#3 consumption, suggesting that the mechanism of action is not directly linked to the microbiota.

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Acknowledgments

This work was supported by NIH grant 5R21 AT003400 and The Children’s Medical Center Research Foundation. The authors would like to acknowledge Ms. Stolfi for her help with the statistical analysis and Mrs. Debra Cunningham for her effort in patient recruitment.

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Correspondence to Sonia Michail.

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Michail, S., Kenche, H. Gut Microbiota is Not Modified by Randomized, Double-Blind, Placebo-Controlled Trial of VSL#3 in Diarrhea-Predominant Irritable Bowel Syndrome. Probiotics & Antimicro. Prot. 3, 1–7 (2011). https://doi.org/10.1007/s12602-010-9059-y

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