Decreasing Abdominal Bloating without Disrupting the Commensal Gut Microbiota - BIO-CAT

The Probiotic Bacillus velezensis strain BV379 Decreases Abdominal Bloating without Disrupting the Commensal Gut Microbiota: A Randomized, Double-Blind, Placebo-Controlled Trial in Healthy Adults​

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Objective

Several spore-forming bacterial Bacillus strains have been substantiated as probiotics. However, little is known about the human probiotic activity of Bacillus velezensis despite its commercial use in animal feed and soil amendments. With a focus on enhancing digestion and gut health, we selected B. velezensis strain BV379 for clinical testing after screening more than 1,000 Bacillus strains for probiotic properties. The efficacy of daily supplementation of BV379 (2 billion CFU/day) for 8 weeks was investigated in a placebo-controlled, parallel design trial in 80 healthy adults. The mean age and body mass index of participants was 50.3 years and 25.9 kg/m2, respectively.

Method

Gastrointestinal symptoms were recorded daily using a questionnaire during the baseline and final weeks. Clinical chemistry, hematology, intestinal permeability (oral 4-sugar probe method), and fecal metagenomic profiles were also investigated at baseline and end of study.

Results

Compared to placebo, a significantly higher percentage of participants showing improvement in abdominal bloating from baseline to week 8 was observed following BV379 supplementation (38.9% vs 17.9%; p = 0.044). There were no clinically meaningful changes in clinical chemistry, hematology, or intestinal permeability between groups. Fecal metagenomic analysis showed no overall perturbations in microbial composition between BV379 and placebo, however a few presumably commensal strains were enriched with BV379 supplementation, in addition to B. velezensis.

Conclusions

Altogether, dietary BV379 supplementation appears to be a safe and well-tolerated approach to support gastrointestinal health.

References

This trial was registered at ClinicalTrials.gov (NCT05595980).
The trial protocol was approved by the Institutional Review Board at Sterling IRB (Atlanta, GA, USA) prior to participant recruitment. B. velezensis strain BV379 is registered at the American Type Culture Collection (ATCC No. PTA-127359). BIO-CAT Microbials, LLC filed a patent application describing the BV379 strain and related compositions and methods of use (U.S. Patent Application No. 63/512,678).