Efficacy and safety of Bacillus coagulans LBSC in irritable bowel syndrome: A prospective, interventional, randomized, double-blind, placebo-controlled clinical study [CONSORT Compliant

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Main idea: B coagulans LBSC are safe for human consumption and efficacious in alleviating overall pathophysiological symptoms of IBS and thereby improving inclusive quality of life.

Abstract

Bacteriotherapy shows a promising impact on alleviating clinical conditions of IBS and associated functional gastrointestinal disorders. B coagulans LBSC is a genetically and phenotypically safe probiotic strain used in this study to evaluate its impact on ameliorating IBS symptoms and improving quality of life.

The goals of the study were to evaluate the safety and efficacy of Bacillus coagulans LBSC in irritable bowel syndrome (IBS) through a prospective interventional randomized double-blind and placebo-controlled CONSORT compliant clinical trial.

In this interventional randomized double-blind placebo-controlled clinical study, a total of 40 subjects (aged 18-65 years) were randomized into 2 groups, that are interventional and placebo arm (n = 20/arm). Similar dosages were received by both arms, that are placebo (vehicle) and interventional arm (B coagulans LBSC, 6 billion/d) for a period of 80 days. The analysis of data from personal questionnaires of the participants showed significant improvement in the interventional arm compared to placebo on symptoms such as bloating, cramping, abdominal pain, diarrhea, constipation, stomach rumbling, nausea, vomiting, headache, and anxiety. Maximum of “no symptoms” cases and mild to moderate gastrointestinal symptoms along with improved stool consistency were from interventional arm tested following IBS severity scoring system and Bristol stool form scale. Upper gastrointestinal endoscopy revealed no clinical difference of gastrointestinal mucosa between both arms. B coagulans LBSC was well tolerated with no serious adverse events.

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