Impact of a Gastrointestinal Stable Probiotic Supplement Bacillus coagulans LBSC on Human Gut Microbiome Modulation

Abstract

Bacillus coagulans LBSC showed stability in acidic pH, bile and simulated human gastrointenstinal juices. Under static gut model, when passed through oral, gastric and intestinal phases, B. coagulans LBSC was found to be stable as free viable spores and also with various foods such as milk and baby foods, as well as American and European diets. In human studies, modulation of gut microbiota by B. coagulans LBSC was comprehended by whole genome metagenome analysis of fecal samples obtained from pre- and post-treatment of irritable bowel syndrome (IBS) patients. B. coagulans LBSC treatment showed positive modulation in gut microbiota, especially up regulation of phyla such as Actinobacteria and Firmicutes, whereas down regulation of Bacteroids, Proteobacteria, Streptophyta and Verrucomicrobia. Simultaneously, it has altered various microbiota associated metabolic pathways to create the normalcy of gut microenvironment.

Keywords:

• B. coagulans
• gastrointestinal stability
• microbiome
• simulated gut model
• whole genome metagenome

Acknowledgements

The authors are grateful and would like to acknowledge Mr. V.L. Rathi and Mr. M. Kabra at Advanced Enzyme Technologies Ltd. for supporting this study.

Data deposition

This project is registered as BioProject (ID: PRJNA608807) in NCBI database. It contains human fecal metagenome data of total ten BioSample; comprising five pretreatment (NCBI Accession No.: SAMN14209466, SAMN14209465, SAMN14209464, SAMN14209463 and SAMN14209462) and five post-treatment (NCBI Accession No.: SAMN14209471, SAMN14209470, SAMN14209469, SAMN14209468 and SAMN14209467) samples to B. coagulans LBSC.

Ethical approval

Human fecal samples used in this study were obtained from a clinical trial which was 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 Approvals were obtained from sites and registration from Clinical Trials Registry - India (CTRI) [Reference No.: CTRI/2018/02/011654 and Dated: 01/02/2018] prior to clinical trial operations.

Declaration of interest

The authors declare that there are no relevant financial and non-financial competing interests exist and no conflict of interest to report. The authors alone are responsible for the content and writing of this article.

Authors contribution

CM, AKG & DBS designed the study protocol, monitored and prepared the manuscript. CM, PB & JK performed the characterization of the isolate and resistance to acid and bile, JK & AIB has done SGIS stability study, YD evaluated the stability at static gut model, microbiome analysis was done by CM and DBS. AKG reviewed the protocol for every analysis and manuscript.

Additional information

Funding

This study was solely funded by Advanced Enzyme Technologies Ltd.

Notes on contributors

Chiranjit Maity

Chiranjit Maity, PhD, a clinical microbiologist with over 10 years’ experience in probiotics, enzymes and metabolites bioprocesses.

Anil Kumar Gupta, PhD

Anil Kumar Gupta, PhD, has over 25 years of experience in industrial microbiology. He is involved in research on microbial enzymes, probiotics and their safety assessment.

Dina B. Saroj

Dina B. Saroj, PhD, has expertise in whole genome sequence analysis and genome modifications for enhanced yield of recombinant proteins and metabolites.

Atul Biyani

Atul Biyani, MSc, is an experienced microbiologist with expertise in enzymes and probiotics processes.

Pratik Bagkar

Pratik Bagkar, MSc, a microbiologist with experience in probiotics research.

Jayshree Kulkarni

Jayshree Kulkarni, PhD, has expertise in regulatory aspects in microbiology and molecular biology research.

Yogini Dixit

Yogini Dixit, PhD, expertise in bioanalytical sciences with experience in microbiological and bioanalytical research.