Original Research Article
Year: 2022 | Month: March | Volume: 12 | Issue: 3 | Pages: 253-264
DOI: https://doi.org/10.52403/ijhsr.20220336
Efficacy and Safety of Probiotic Bacillus coagulans-SNZ 1969 in Gastrointestinal Discomfort: A Randomized, Placebo-Controlled Study
Raunak J Soman1, Kiranjit Singh2, Malisetty Venkat Swamy3
1Executive Director, Research and Development, Sanzyme Biologics Pvt. Ltd., Hyderabad 500034, India.
2Consultant in Internal Medicine, Jehangir Hospital, Pune 411001, India.
3Chief Technical Officer, Sanzyme Biologics Pvt. Ltd., Hyderabad 500034, India.
Corresponding Author: Raunak J Soman
ABSTRACT
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.