A prospective, interventional, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of Bacillus coagulans LBSC in the treatment of acute diarrhea with abdominal discomfort

Abstract

Purpose: Increasing resistance towards antibiotics has augmented the use of probiotics for the treatment of diarrhea and associated symptoms. Probiotics are active microorganisms which exert some health benefits when consumed in the right amount. This randomized, double-blind, placebo-controlled clinical trial was conducted on 60 "intention to treat" subjects to evaluate the safety and efficacy of probiotic preparation Lactic Acid Bacillus (LAB containing active ingredient Bacillus coagulans strain LBSC) for the treatment of acute diarrhea with abdominal discomfort.

Methods: The Test-A arm (n = 30) was on B. coagulans LBSC [2 billion/g] and Placebo-B arm (n = 30) was on the carrier. The primary outcomes were the time to last unformed stool (TTLUS), number of unformed stools, change in severity of abdominal pain, time to complete resolution of abdominal discomfort, complete remission of diarrhea, and quality of life (QoL). The secondary outcomes were physical examination and vitals, hematological analysis, and assessment of reported adverse events (AEs) or serious adverse events (SAEs).

Results: Trial data showed that the LAB was well-tolerated by participants at the dose provided. The LAB was effective in recovering from acute diarrhea with abdominal pain and discomforts and exhibited improved cluster of QoL. No AEs or SAEs were reported during the trial.

Conclusions: It is evident that the test drug, i.e., LAB (B. coagulans strain LBSC) is safe and effective for improving the pathophysiological conditions related to acute diarrhea and abdominal discomfort evaluated through stage-II clinical trial.

Keywords: Abdominal pain; Bacillus coagulans; Bristol stool scale; Diarrhea; Quality of life.