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

GOALS: To evaluate safety and efficacy of Bacillus coagulans LBSC [DSM17654] in irritable bowel syndrome (IBS) through a prospective, interventional, randomized, double-blind, and placebo-controlled, CONSORT compliant clinical trial. BACKGROUND: Bacteriotherapy shows 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 study its impact on ameliorating IBS symptoms and improving quality of life. METHODS: In this interventional, randomized, double-blind, placebo-controlled clinical study, total 40 subjects (18-65 years) were screened through Rome IV criteria and randomized into 2 groups, that is, interventional and placebo arm (n = 20/arm). Similar dosages were received by both the arm, that is, placebo (vehicle) and interventional arm (B coagulans LBSC, 6 billion/d) for a period of 80 days. Study completed with per protocol subjects (n = 38) and results were considered to evaluate the primary and secondary endpoints. RESULTS: Assessment through Digestive Symptom Frequency Questionnaire 5 point Likert scale showed significant improvement in 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 the arms. B coagulans LBSC was well tolerated with no serious adverse events. CONCLUSIONS: B coagulans LBSC was safe for human consumption and efficacious in alleviating overall pathophysiological symptoms of IBS and thereby improving inclusive quality of life evaluated.