Open AccessEfficacy and Safety of Probiotic Bacillus coagulans-SNZ 1969 in Gastrointestinal Discomfort: A Randomized, Placebo-Controlled Study
Author(s) -
Raunak J Soman,
Kiranjit Singh,
Malisetty V. Swamy
Publication year - 2022
Publication title -
international journal of health sciences and research
Language(s) - English
Resource type - Journals
ISSN - 2249-9571
DOI - 10.52403/ijhsr.20220336
Subject(s) - medicine , placebo , bacillus coagulans , probiotic , randomized controlled trial , discontinuation , adverse effect , meal , gastroenterology , placebo controlled study , double blind , food science , chemistry , alternative medicine , pathology , biology , fermentation , bacteria , genetics
Purpose: Bacillus coagulans-based probiotics restore gut microbiota and alleviate symptoms of gastrointestinal (GI) discomfort. This study evaluated the efficacy and safety of SNZ 1969 in individuals with GI discomfort.Methods: This was a single-center, randomized, placebo-controlled, parallel‑arm, double-blind study. Participants with GI discomfort (n=30 in each arm) without a specific pathology were randomized to receive B. coagulans‑SNZ 1969, TriBac, or placebo, once daily after a major meal, for 30 days. Symptoms were assessed using the Severity of Dyspepsia Assessment (SODA) scale, Gastrointestinal Symptom Rating Scale (GSRS), and Short Form 36 (SF-36) at baseline, day 15, day 30, and 7 days after the end of treatment.Results: A total of 29 participants from SNZ 1969 and 28 from the placebo group completed the study. Treatment with SNZ 1969 significantly improved the total SODA score (18.34 ± 5.35 vs. 12.60 ± 4.79; p < 0.001), SODA subscores for pain intensity (15.41 ± 4.98 vs. 10.71 ± 3.68; p < 0.001), nonpain symptoms (7.28 ± 2.23 vs. 4.89 ± 2.94; p < 0.001), satisfaction (−4.43 ± 1.81 vs. −3.00 ± 1.22; p = 0.002), and symptom of sour taste (1.52 ± 0.78 vs. 0.75 ± 0.89; p = 0.001) compared with placebo and were consistent after 7 days of treatment discontinuation (p < 0.05). No significant score reduction was observed for GSRS compared with placebo. Two adverse events, fever and cold, were unrelated to SNZ 1969.Conclusion: SNZ 1969 was found to be safe and effective in reducing GI discomfort, especially dyspepsia.Key words: Bacillus coagulans, Gastrointestinal discomfort, Gastrointestinal Symptom Rating Scale, Probiotic, SNZ 1969, Severity of Dyspepsia Assessment scale.