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

  • 2023-05-19
  • Medicine 102(20)
    • M. Majeed
    • K. Nagabhushanam
    • Lakshmi A Mundkur
    • Shaji Paulose
    • H. Divakar
    • Sudha Rao
    • S. Arumugam

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 probiotic-supplemented 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.

Research Insights

SupplementHealth OutcomeEffect TypeEffect Size
Bacillus coagulansAbsence of Adverse EventsNeutral
Large
Bacillus coagulansBalanced Gut MicrobiomeNeutral
Small
Bacillus coagulansIncreased Beneficial Gut BacteriaBeneficial
Small
Bacillus coagulans LactoSpore 1 billion CFUImproved Stability of Gut MicrobiotaNeutral
Small
Bacillus coagulans LactoSpore 1 billion CFUIncreased Beneficial Gut BacteriaBeneficial
Small
Bacillus coagulans MTCC 5856Balanced Gut MicrobiomeNeutral
Small
Bacillus coagulans MTCC 5856Increased Beneficial Gut BacteriaBeneficial
Small
Bacillus coagulans MTCC 5856Safety of ConsumptionBeneficial
Moderate
Bacillus coagulans ProDuraAbsence of Adverse EventsNeutral
Large
Bacillus coagulans ProDuraIncreased Beneficial Bacterial SpeciesBeneficial
Small
Bacillus coagulans ProDuraMaintained Gut Microbiome CompositionNeutral
Small
Bacillus coagulans SC208Balanced Gut MicrobiomeNeutral
Small
Bacillus coagulans SC208Improved Abundance of Beneficial BacteriaBeneficial
Small
Bacillus coagulans SNZ-1969Balanced Gut MicrobiomeNeutral
Small
Bacillus coagulans SNZ-1969Increased Beneficial Gut BacteriaBeneficial
Small
Bacillus coagulans SNZ-1969Safety of ConsumptionBeneficial
Moderate
Bacillus coagulans Unique IS-2Improved Stability of Gut MicrobiotaNeutral
Small
Bacillus coagulans Unique IS-2Increased Beneficial Bacterial SpeciesBeneficial
Small
Bacillus coagulans Unique IS-2Safety for ConsumptionNeutral
Large
LactoSporeAbsence of Adverse EventsNeutral
Large
LactoSporeImproved Gut HealthNeutral
Small
LactoSporeIncreased Beneficial Gut BacteriaBeneficial
Small
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