A probiotic amylase blend reduces gastrointestinal symptoms in a randomised clinical study

Abstract

A randomised, placebo-controlled, double-blind, parallel clinical study was performed to examine the effects of a probiotic- amylase (PRO) blend on gastrointestinal (GI) symptoms. Sixty men and women (44.4 ± 8.9 yr; 82.0 ± 18.4 kg; 170.3 ± 11.5 cm; 28.1 ± 4.6 kg/m2) were randomised into PRO (n = 29) or placebo (PLA: n = 31) groups. Participants exhibited mild to moderate GI symptoms and severity [via Gastrointestinal Symptom Rating Scale (GSRS)] to be eligible for participation. Participants were tested before (Baseline) and after (POST) 6 weeks of supplementation on various gastrointestinal indices, the GSRS (to assess GI symptoms, frequency, and severity), an anxiety questionnaire (GAD-7), and an overall well-being questionnaire (SF-36). Two (PRO vs PLA) × 2 (Baseline vs POST) mixed factorial ANOVAs were completed to assess group, time, and (group × time) interaction effects. Fifty-two subjects who completed the entire study were analysed (PRO: n = 25, PLA: n = 27). There were statistically significant (P ≤ 0.05) interactions for bloating, GSRS score, and abdominal discomfort but time effects for flatulence, constipation, stool regularity, and GAD-7 total score. PRO significantly reduced GSRS score (~60 vs 25%, d = 0.72), bloating (~49% vs 25%, d = -0.63) and abdominal discomfort (59% vs 32%, d = -0.66) to a greater degree than PLA. PRO significantly reduced subjective feelings of irritability, pain, and overall health interference. Oral supplementation of the probiotic-amylase blend was very well tolerated. Our study showed that the probiotic-amylase blend reduced the GSRS score and other GI symptoms to a greater degree than PLA. Clinical trial registration: clinicaltrials.gov #NCT05614726.