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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

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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.

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Acknowledgements

Authors are grateful to Mr. V.L. Rathi, Mr. C.L. Rathi, Mr. Mukund Kabra, and Mr. Piyush Rathi at Advanced Enzyme Technologies Ltd. for their technical inputs and providing the laboratory facilities to carry out the study.

Author contribution statement

CM designed the study protocol, and monitored and prepared the manuscript. AKG reviewed the protocol and manuscript, and approved with technical inputs.

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Authors and Affiliations

  1. Probiotics Laboratory, Advanced Enzyme Technologies Ltd., 5th Floor, A-Wing, Sun Magnetica, LIC Service Road, Louiswadi, Thane (W), Maharashtra, 400 604, India

    Chiranjit Maity & Anil Kumar Gupta

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  1. Chiranjit Maity
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Correspondence to Chiranjit Maity.

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The authors declare that they have no conflict of interest.

Ethical approval

This study is conducted in compliance with the applicable ethical standards Harmonized Tripartite Guidelines for Good Clinical Practice (GCP), the relevant sections of Good Laboratory Practice (GLP), local laws and regulations, and the provisions of the Declaration of Helsinki. The EC Approval [Reference No.: RH/IEC/AP-002/2018 and Dated: 16/01/2018] and registration of the Clinical Trials Registry—India (CTRI) [Reference No.: CTRI/2018/01/011635 and Dated: 31/01/2018] were obtained prior to the clinical trial study.

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Maity, C., Gupta, A.K. 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. Eur J Clin Pharmacol 75, 21–31 (2019). https://doi.org/10.1007/s00228-018-2562-x

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