Evaluation of efficacy and safety of Bacillus coagulans SNZ 1969 supplementation for irritable bowel syndrome: a randomized, double-blind, placebo-controlled study

Raunak J. Soman; Sarath Chandra Gorantla; Malisetty Venkat Swamy

doi:10.18203/2319-2003.ijbcp20222353

Authors

Raunak J. Soman Sanzyme Biologics Pvt. Ltd., Hyderabad, Telangana, India
Sarath Chandra Gorantla Department of Medical Gastroenterology, Apollo Hospitals, Jubilee Hills, Hyderabad, Telangana, India
Malisetty Venkat Swamy Sanzyme Biologics Pvt. Ltd., Hyderabad, Telangana, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20222353

Keywords:

Bacillus coagulans, Gastrointestinal symptom rating scale, Functional gastrointestinal disorder, Lactic acid-producing bacteria, Probiotics, SF-8 health survey, IBS-C, IBS-D, SNZ 1969

Abstract

Background: Probiotic potential (efficacy and safety) of Bacillus coagulans SNZ 1969 has been studied in patients with constipation-predominant irritable bowel syndrome (IBS-C) and-diarrhea predominant IBS (IBS-D).

Methods: This randomized, double-blind, two-arm, placebo-controlled parallel study randomized 92 patients (1:1) to receive either 500 million CFU of Bacillus coagulans SNZ 1969 (treatment group) or placebo (placebo group) twice daily for 60 days under two subtypes of IBS, IBS-D (n=46) and IBS-C (n=46). Primary outcomes were changes in IBS symptom severity noted using the gastrointestinal symptom rating scale-IBS version (GSRS-IBS) on days 30, 60, and 75, and the number of treatment responders defined by subject’s global assessment (SGA) of relief ≤3 and ≤2 at days 30 and 60, respectively. We also assessed patient’s quality of life.

Results: The GSRS-IBS scores reduced from day 30 through 75 in both IBS groups treated with Bacillus coagulans SNZ1969 compared to placebo (p<0.05). Higher GSRS-IBS score was noted in patients with IBS-C in the treatment group (22.45±2.7) than the placebo group (3.55±3.02; p<0.0001), and this trend was similar in IBS-D patients (p<0.0001). Most patients (90%) with IBS-C and all with IBS-D responded to Bacillus coagulans SNZ 1969 compared to no responders with placebo (p<0.0001). The SF-8 scores significantly reduced in patients receiving Bacillus coagulans SNZ 1969 than placebo for both IBS subtypes. One adverse event unrelated to the study treatments was reported in IBS-D group.

Conclusions: Bacillus coagulans SNZ 1969 is safe, effective in alleviating IBS-associated clinical symptoms, and improves quality of life.

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