A prospective, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of SNZ TriBac, a three-strain Bacillus probiotic blend for undiagnosed gastrointestinal discomfort

Abstract

Purpose: This prospective, randomized, double-blind, placebo-controlled, parallel-group study aimed to determine the efficacy and safety of a multistrain (Bacillus coagulans [SNZ 1969], Bacillus clausii [SNZ 1971], and Bacillus subtilis [SNZ 1972]) probiotic blend (SNZ TriBac) in managing symptoms of gastrointestinal (GI) discomfort in the absence of specific pathologies.

Methods: Sixty adults with symptoms of GI discomfort were enrolled (mean age, 34.89 ± 9.95 years) and randomized to receive either SNZ TriBac or placebo. Changes from baseline in Severity of Dyspepsia Assessment (SODA), Gastrointestinal Symptom Rating Scale (GSRS), and Quality of Life (QoL) scales over the course of product use were determined at baseline and on days 30 and 37 as study outcomes.

Results: On day 30, significant improvement with SNZ TriBac was noted in SODA burping/belching (P = 0.025), bloating (P = 0.048), sour taste (P = 0.025), and total (P = 0.007) scores as well as pain (P = 0.003), non-pain (P = 0.04), and satisfaction (P = 0.03) subscores. Significant improvement with SNZ TriBac was also observed in SODA burping/belching (P = 0.011), sour taste (P = 0.011), and total SODA scores (P < 0.001), and in SODA pain (P = 0.005), non-pain (P = 0.06), and satisfaction (P = 0.004) subscores on day 37. No adverse events were reported.

Conclusion: Significant improvement in final SODA scores and subscores with SNZ TriBac versus placebo indicates improvement in several symptoms of gastrointestinal discomfort. This multistrain probiotic blend was well tolerated and could be an effective option for treatment of GI discomfort.

Trial registration: Clinical Trials Registry of India (CTRI/2018/05/014071).

Keywords: Bacillus clausii; Bacillus coagulans; Bacillus subtilis; Gastrointestinal discomfort; Probiotic.