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
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.
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.
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.
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.
Clinical Trials Registry of India (CTRI/2018/05/014071)
KeywordsGastrointestinal discomfort Probiotic Bacillus coagulans Bacillus clausii Bacillus subtilis
The authors would like to thank JCDC, Pune, for conducting and analyzing the data of this study and CBCC Global Research for providing medical writing assistance for development of this manuscript.
All authors made substantial contributions to study conception, acquisition of data, and preparation of this manuscript. All authors read and approved the final version of this manuscript.
The study was funded by Sanzyme Biologics Pvt. Ltd., India.
Compliance with ethical standards
Before participation in the study, all subjects provided written informed consent. This study was performed in compliance with International Conference on Harmonisation (ICH E6[R2]) “Guidance on Good Clinical Practice,” Declaration of Helsinki; Indian Good Clinical Practices Guideline; National Ethical Guidelines for Biomedical and Health Research involving human participants, Indian Council of Medical Research 2017; and, relevant standard operating protocols of Jehangir Clinical Development Centre, Pune, Maharashtra, India. This study was approved by the institutional review board of Jehangir Clinical Development Centre, Pune, Maharashtra, India, and was registered in the Clinical Trials Registry of India (CTRI/2018/05/014071).
Conflict of interest
R J Soman and M V Swamy are employees of Sanzyme Biologics Pvt Ltd. The authors have no other conflict of interest to declare with respect to this authored publication.
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