Probiotic modulation of gut microbiota by Bacillus coagulans MTCC 5856 in healthy subjects: A randomized, double-blind, placebo-control study

Abstract

Background: Probiotics are known to rebalance the gut microbiota in dysbiotic individuals, but their impact on the gut microbiome of healthy individuals is seldom studied. The current study is designed to assess the impact and safety of Bacillus coagulans (Weizmannia coagulans) microbial type culture collection 5856 (LactoSpore®) supplementation on microbiota composition in healthy Indian adults.Methods: The study participants (N = 30) received either LactoSpore (2 billion colony-forming units/capsule) or placebo for 28 days. The general and digestive health were assessed through questionnaires and safety by monitoring adverse events. Taxonomic profiling of the fecal samples was carried out by 16S rRNA amplicon sequencing using the Illumina MiSeq platform. The bacterial persistence was enumerated by quantitative reverse transcription-polymerase chain reaction.Results: Gut health, general health, and blood biochemical parameters remained normal in all the participants. No adverse events were reported during the study. Metataxonomic analysis revealed minimal changes to the gut microbiome of otherwise healthy subjects and balance of Bacteroidetes and Firmicutes was maintained by LactoSpore. The relative abundance of beneficial bacteria like Prevotella, Faecalibacterium, Blautia, Megasphaera, and Ruminococcus showed an increase in probioticsupplemented individuals. The quantitative polymerase chain reaction analysis revealed highly variable numbers of B. coagulans in feces before and after the study. Conclusion:The present study results suggest that LactoSpore is safe for consumption and does not alter the gut microbiome of healthy individuals. Minor changes in a few bacterial species may have a beneficial outcome in healthy individuals. The results reiterate the safety of B. coagulans microbial type culture collection 5856 as a dietary supplement and provide a rationale to explore its effect on gut microbiome composition in individuals with dysbiosis.

Overview of Probiotic Strains of Weizmannia coagulans, Previously Known as Bacillus coagulans, as Food Supplements and Their Use in Human Health

“…Twenty-five randomised controlled clinical trials [24,25, used single-strain Weizmannia coagulans probiotics. The most used strain (9 clinical trials) was GBI-30, 6086 [45,46,48,54,[56][57][58][59][60], followed by 5 clinical trials with the strain Unique IS-2 [25,41,47,51,53], 5 clinical trials with MTCC 5856 [24,38,39,44,55], and 2 clinical trials with LBSC (DSM 17654) [42,52]. The remaining four clinical trials were each conducted with a different strain, namely TBC169 [40], SNZ 1969 [43], BC30 [49], and T11 (IBRC-M10791) [50].…”

“…The remaining four clinical trials were each conducted with a different strain, namely TBC169 [40], SNZ 1969 [43], BC30 [49], and T11 (IBRC-M10791) [50]. The investigated beneficial effects of the probiotic strains included relieving symptoms of irritable bowel syndrome [42,46,51,53,55,58,59], constipation, diarrhoea, and other gastrointestinal symptoms [24,25,43,47,48,52,56,60], modulation of gut microbiota [38], function recovery treatment of non-fatty liver disease [45], after surgery [40] or in patients with rheumatoid arthritis [57], quality of life and glucose-and lipid-related biomarkers related to overweight or obese participants [44,49] or diabetic patients [50], absorption of protein or muscle integrity [41,54], and the skin anti-aging effect [39]. All clinical studies found at least one health benefit.…”

Probiotic Weizmannia coagulans MTCC 5856 as adjunct therapy in children's acute diarrhea—a randomized, double-blind, placebo-controlled study

“…In addition, the strain produces organic acid (lactic acid) and short-chain fatty acids (SCFAs), which may lower the pH of the gut cavity, thereby inhibiting the growth of pathogens. These short-chain fatty acids play a pivotal role in the maintenance of overall gut health, intestinal morphology, and function ( 27 , 30 , 49 ). Moreover, W. coagulans MTCC 5856 is reported to have immunomodulatory properties in human colonic cells, which make the spores efficacious in the management of infectious diarrhea ( 50 ).…”

“…Furthermore, oral administration of W. coagulans MTCC 5856 safely improved overall gut health in diarrhea predominant irritable bowel syndrome (IBS) patients (25). Recent studies have shown that it has therapeutic effects on intestinal diseases, such as acute diarrhea, antibiotic-related diarrhea, constipation, and colitis, via modulation of the microbiota composition, host immunity, and metabolism (25)(26)(27)(28)(29). Additionally, toxicological experiments and many clinical observations have shown that W. coagulans is safe and has no effect of mutagenicity, teratogenicity, or genotoxicity (28,30).…”

Modern probiotics in the treatment of sexually transmitted infections. From the problem to its solution

“…Пробіотичні організми підтримують корисні захисні бактерії, що містяться у системі травлення. Ці мікроорганізми необхідні для засвоєння поживних речовин і балансу кишкової флори [21].…”