Randomized clinical trial: the effect of probiotic Bacillus coagulans Unique IS2 vs. placebo on the symptoms management of irritable bowel syndrome in adults

Ratna Sudha Madempudi,Jayanthi Neelamraju,Jayesh J Ahire,Satyavrat Nanal,Anirudh Tripathi

doi:10.1038/s41598-019-48554-x

Ratna Sudha Madempudi, Jayanthi Neelamraju + Show 3 more

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https://doi.org/10.1038/s41598-019-48554-x

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Journal: Scientific Reports	Publication Date: Aug 21, 2019
Citations: 46	License type: open-access

Affiliation: Biotech Park

Abstract

The therapeutic effects of B. coagulans Unique IS2 have been well established in children with irritable bowel syndrome (IBS), but its efficacy in adults remain under reported. Thus, in this study the efficacy of B. coagulans Unique IS2 in the management of IBS symptoms in adults was investigated. Patients (n = 153) fulfilling Rome III criteria were provided placebo capsules for a 2 weeks run-in period. Only patients satisfying compliance criteria (n = 136) were randomized (double blind) to receive either B. coagulans Unique IS2 (2 billion CFU) or placebo capsules daily for 8 weeks. Reduction of abdominal discomfort/pain intensity and increase in complete spontaneous bowel movements were analyzed as primary end points. Other clinical symptoms of IBS and serum cytokines were also evaluated. B. coagulans Unique IS2 showed significant improvement in primary and secondary endpoints, as compared to placebo. Haematology of both the arms remained normal. No significant changes in pro- (IL-6, IL-12, TNF-α, INF- γ) and anti-inflammatory cytokine (IL-10) levels were detected at the end of B. coagulans treatment (8 weeks) as compared to placebo. B. coagulans was well tolerated with no severe adverse events to report. Overall, the results demonstrate that B. coagulans Unique IS2 is efficacious in the management of IBS symptoms in adults (18–60 years).

Highlights

Irritable bowel syndrome (IBS) is a chronic gastrointestinal tract disorder known to cause severe abdominal pain due to changes in normal gut behavior[1,2]
In the present double blind, randomised controlled study, we investigated the effect of B. coagulans Unique IS2 supplementation on abdominal pain, complete spontaneous bowel movement (CSBM) and disease severity in adults (18–60 years) with irritable bowel syndrome (IBS)
Mean complete spontaneous bowel movements (CSBMs) score observed at baseline was 2.5 (B. coagulans) and 2.2 (p = 0.2825)

Summary

Introduction

Irritable bowel syndrome (IBS) is a chronic gastrointestinal tract disorder known to cause severe abdominal pain due to changes in normal gut behavior[1,2]. According to Rome IV diagnostic criteria, IBS is defined as a functional bowel disorder (FBD) in which patient reports recurrent abdominal pain on an average at least one day in a week in the last 3 months, associated with two or more symptoms such as pain during defecation, change in stool frequency and stool form[2,3]. We have shown that B. coagulans Unique IS2 supplementation reduced abdominal pain, discomfort and disease severity and improved the stool consistency in children (4–12 years) with IBS22. In the present double blind, randomised controlled study, we investigated the effect of B. coagulans Unique IS2 supplementation on abdominal pain, complete spontaneous bowel movement (CSBM) and disease severity in adults (18–60 years) with irritable bowel syndrome (IBS)

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