A prospective, randomized, open-label, placebo-controlled comparative study of Bacillus coagulans GBI-30,6086 with digestive enzymes in improving indigestion in geriatric population

V Vasanth Kumar; Kulur Mukhyaprana Sudha; Shilpa Bennur; Karukkupalayam Ramasamy Dhanasekar

doi:10.4103/jfmpc.jfmpc_922_19

A prospective, randomized, open-label, placebo-controlled comparative study of Bacillus coagulans GBI-30,6086 with digestive enzymes in improving indigestion in geriatric population

J Family Med Prim Care. 2020 Feb 28;9(2):1108-1112. doi: 10.4103/jfmpc.jfmpc_922_19. eCollection 2020 Feb.

Authors

V Vasanth Kumar¹, Kulur Mukhyaprana Sudha¹, Shilpa Bennur², Karukkupalayam Ramasamy Dhanasekar²

Affiliations

¹ Institute of Pharmacology, Madras Medical College, Chennai, Tamil Nadu, India.
² Department of Medical and Scientific Affairs, Tablets India Limited, Chennai, Tamil Nadu, India.

Abstract

Introduction: Digestive symptoms are common affecting more than 60% of the elderly people. Digestive enzyme deficiency and dysbiosis in the gastric fluid microbiota are the major contributors in the pathophysiology of indigestion. Therefore, therapeutic strategy targeting the gastric microbiota and digestive enzymes has the potential to treat indigestion. This study was conducted to evaluate the efficacy and tolerability of probiotic Bacillus coagulans GBI30,6086 along with digestive enzymes in improving indigestion in geriatric population.

Methods: An open-labelled, randomized, prospective study was conducted in geriatric patients with complaints of indigestion. The study group (n = 25) received 5 ml of reconstituted probiotic syrup containing Bacillus coagulans GBI-30, 6086, and digestive enzymes daily and the control group (n = 25) received 5 ml of placebo syrup twice daily for 5 days and followed-up after 7 days.

Results: Reduction in Modified Glasgow dyspepsia severity score from baseline to follow up was statistically significant in the study group when compared to the control group (P < 0.0001). Improvement in indigestion, abdominal pain, and flatulence was also greater in the study group compared to the control group.

Conclusion: Bacillus coagulans along with digestive enzymes are effective in treating indigestion in geriatric patients. It is well tolerated and safe to be used in geriatric patients without any major adverse effects.

Keywords: Bacillus coagulans; digestive enzymes; geriatrics; indigestion.