Evaluation of Bacillus coagulans LMG S-31876 for immunomodulation and stress: a double-blind, placebo-controlled clinical trial

ObjectiveThe study aimed to analyze the safety and effectiveness of the ProBC Plus (Bacillus coagulans LMG S-31876) supplement across various health parameters, including stress levels, immunoglobulin levels, biochemical parameters, and vital signs.MethodsA randomized, double-blind, placebo-controll...

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Main Authors: Ranjith Kumar Kallur, Sreenadh Madapati, Mayuri Banerjee, Ankita Mathur, Sourish Bhattacharya
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-01-01
Series:Frontiers in Nutrition
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Online Access:https://www.frontiersin.org/articles/10.3389/fnut.2024.1484499/full
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author Ranjith Kumar Kallur
Sreenadh Madapati
Mayuri Banerjee
Ankita Mathur
Sourish Bhattacharya
author_facet Ranjith Kumar Kallur
Sreenadh Madapati
Mayuri Banerjee
Ankita Mathur
Sourish Bhattacharya
author_sort Ranjith Kumar Kallur
collection DOAJ
description ObjectiveThe study aimed to analyze the safety and effectiveness of the ProBC Plus (Bacillus coagulans LMG S-31876) supplement across various health parameters, including stress levels, immunoglobulin levels, biochemical parameters, and vital signs.MethodsA randomized, double-blind, placebo-controlled clinical trial study was conducted involving 50 subjects diagnosed with ailments related to immune system dysfunction and stress related disorders. Patients were treated with ProBC Plus (2 billion colony-forming units [CFU]) along with a placebo capsule administered once daily for a period of 8 weeks.ResultsThe effects of ProBC Plus exhibited a positive response on stress relief, lipid parameters, immune status, and vital signs, which is further statistically significant (p value <0.05, 5% marginal error at 95% CI).ConclusionThe study on ProBC Plus showed positive results. Over the course of 8 weeks, an improvement in the immune status was observed, as indicated by the immune status questionnaire. Enzymatic markers exhibited a significant decline in predicting a positive response toward 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 vital signs remained within the normal range throughout the study. Therefore, ProBC Plus is considered safe for consumption and contributes to the overall well-being of individuals.Clinical trial registrationhttps://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=77914&EncHid=24313.96864&userName=CTRI/2023/01/048720, CTRI/2023/01/048720.
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issn 2296-861X
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publishDate 2025-01-01
publisher Frontiers Media S.A.
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spelling doaj-art-e6dac7847e464d34943b731a103939a62025-01-15T05:10:21ZengFrontiers Media S.A.Frontiers in Nutrition2296-861X2025-01-011110.3389/fnut.2024.14844991484499Evaluation of Bacillus coagulans LMG S-31876 for immunomodulation and stress: a double-blind, placebo-controlled clinical trialRanjith Kumar Kallur0Sreenadh Madapati1Mayuri Banerjee2Ankita Mathur3Sourish Bhattacharya4Abode Biotec India Pvt. Ltd., Hyderabad, Telangana, IndiaAbode Biotec India Pvt. Ltd., Hyderabad, Telangana, IndiaAbode Biotec India Pvt. Ltd., Hyderabad, Telangana, IndiaAbode Biotec India Pvt. Ltd., Hyderabad, Telangana, IndiaProcess Design and Engineering Cell, CSIR-Central Salt and Marine Chemicals Research Institute, Bhavnagar, Gujarat, IndiaObjectiveThe study aimed to analyze the safety and effectiveness of the ProBC Plus (Bacillus coagulans LMG S-31876) supplement across various health parameters, including stress levels, immunoglobulin levels, biochemical parameters, and vital signs.MethodsA randomized, double-blind, placebo-controlled clinical trial study was conducted involving 50 subjects diagnosed with ailments related to immune system dysfunction and stress related disorders. Patients were treated with ProBC Plus (2 billion colony-forming units [CFU]) along with a placebo capsule administered once daily for a period of 8 weeks.ResultsThe effects of ProBC Plus exhibited a positive response on stress relief, lipid parameters, immune status, and vital signs, which is further statistically significant (p value <0.05, 5% marginal error at 95% CI).ConclusionThe study on ProBC Plus showed positive results. Over the course of 8 weeks, an improvement in the immune status was observed, as indicated by the immune status questionnaire. Enzymatic markers exhibited a significant decline in predicting a positive response toward 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 vital signs remained within the normal range throughout the study. Therefore, ProBC Plus is considered safe for consumption and contributes to the overall well-being of individuals.Clinical trial registrationhttps://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=77914&EncHid=24313.96864&userName=CTRI/2023/01/048720, CTRI/2023/01/048720.https://www.frontiersin.org/articles/10.3389/fnut.2024.1484499/fullProBC Plus (Bacillus coagulans LMG S-31876)immune systemstressclinical trialshealthplacebo
spellingShingle Ranjith Kumar Kallur
Sreenadh Madapati
Mayuri Banerjee
Ankita Mathur
Sourish Bhattacharya
Evaluation of Bacillus coagulans LMG S-31876 for immunomodulation and stress: a double-blind, placebo-controlled clinical trial
Frontiers in Nutrition
ProBC Plus (Bacillus coagulans LMG S-31876)
immune system
stress
clinical trials
health
placebo
title Evaluation of Bacillus coagulans LMG S-31876 for immunomodulation and stress: a double-blind, placebo-controlled clinical trial
title_full Evaluation of Bacillus coagulans LMG S-31876 for immunomodulation and stress: a double-blind, placebo-controlled clinical trial
title_fullStr Evaluation of Bacillus coagulans LMG S-31876 for immunomodulation and stress: a double-blind, placebo-controlled clinical trial
title_full_unstemmed Evaluation of Bacillus coagulans LMG S-31876 for immunomodulation and stress: a double-blind, placebo-controlled clinical trial
title_short Evaluation of Bacillus coagulans LMG S-31876 for immunomodulation and stress: a double-blind, placebo-controlled clinical trial
title_sort evaluation of bacillus coagulans lmg s 31876 for immunomodulation and stress a double blind placebo controlled clinical trial
topic ProBC Plus (Bacillus coagulans LMG S-31876)
immune system
stress
clinical trials
health
placebo
url https://www.frontiersin.org/articles/10.3389/fnut.2024.1484499/full
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