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CLINICAL TRIAL article

Front. Nutr.
Sec. Nutrition and Microbes
Volume 11 - 2024 | doi: 10.3389/fnut.2024.1484499
This article is part of the Research Topic Probiotics for Global Health: Advances, Applications and Challenges View all 14 articles

Evaluation of Bacillus coagulans LMG S-31876 on Immunomodulation and Stress: A Double-Blind, Placebo-Controlled Clinical Trial

Provisionally accepted
Ranjith Kumar Kallur Ranjith Kumar Kallur 1Sreenadh Madapati Sreenadh Madapati 1Ankita Mathur Ankita Mathur 1Mayuri Banerjee Bhattacharya Mayuri Banerjee Bhattacharya 1Sourish Bbhattacharya Sourish Bbhattacharya 2*
  • 1 Abode Biotec India Private Limited, Hyderabad, Andhra Pradesh, India
  • 2 Central Salt & Marine Chemicals Research Institute (CSIR), Bhavnagar, India

The final, formatted version of the article will be published soon.

    Objective: The study aimed to analyze the safety and also its effectiveness of ProBC Plus (Bacillus coagulans LMG S-31876) supplement, on various health parameters, including stress levels, immunoglobulin levels, biochemical parameters, as well as vital signs.Methodology: A randomized, double-blind, placebo-controlled clinical trial study was designed. This study involved (n=50) subjects diagnosed with ailments related to immune system dysfunctional and stress related disorders. Patients were treated with ProBC Plus (2 billion CFU) along with placebo capsule once daily for a period of 8 weeks.The impact of ProBC Plus exhibited a positive response on stress relief, lipid parameters, immune status, as well as on vital signs, which is further statistically significant (p value <0.05, 5 % marginal error at 95 % CI).The study on ProBC Plus exhibited a positive outcome. An improvement in the immune status was seen over the eight weeks, as indicated by the immune status questionnaire.Enzymatic markers exhibited a significant decline in predicting a positive response towards treatment. In terms of lipid profile, ProBC Plus helps to maintain the value within the normal range thereby predicting its potential as cardiovascular support. The vitals remained within the normal range throughout the study. Therefore, ProBC Plus is safe for consumption for the overall well-being of individuals.Clinical trial registration: Clinical trials were registered in CTRI with number CTRI/2023/01/048720,https://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=77914&EncHid =24313.96864&userName=CTRI/2023/01/048720.

    Keywords: ProBC Plus (Bacillus coagulans LMG S-31876), Immune System, stress, clinical trials, Health, placebo

    Received: 21 Aug 2024; Accepted: 23 Dec 2024.

    Copyright: © 2024 Kallur, Madapati, Mathur, Bhattacharya and Bbhattacharya. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Sourish Bbhattacharya, Central Salt & Marine Chemicals Research Institute (CSIR), Bhavnagar, India

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.