Bacillus Subtilis (BG01-4TM) Improves Self-Reported Symptoms for Constipation, Indigestion, and Dyspepsia: A Phase 1/2A Randomized Controlled Trial

消化不良 医学 安慰剂 便秘 内科学 功能性便秘 随机对照试验 临床试验 胃肠病学 物理疗法 肠易激综合征 替代医学 病理
作者
Craig S Patch,Alan J. Pearce,Mek Cheng,Ray Boyapati,J. Thomas Brenna
出处
期刊:Nutrients [MDPI AG]
卷期号:15 (21): 4490-4490 被引量:9
标识
DOI:10.3390/nu15214490
摘要

Background: Functional gastrointestinal disorders (FGIDs) are common, difficult-to-manage conditions. Probiotics are emerging as a dietary component that influence gastrointestinal (GI) health. We conducted a double-blinded randomised controlled trial of a proprietary strain of deactivated Bacillus subtilis (BG01-4™) high in branched-chain fatty acids (BCFA) to treat self-reported FGID. Methods: Participants (n = 67) completed a four-week intervention of BG01-4™ (n = 34) or placebo (n = 33). The Gastrointestinal Symptom Rating Scale (GSRS) served as the outcome measure, collected prior to, at two weeks, and at four weeks after completion of the intervention. Results: At four weeks, one of three primary outcomes, constipation in the experimental group, was improved by 33% compared to placebo (15%); both other primary outcomes, Total GSRS and diarrhoea, were significantly improved in both the experimental and placebo groups (32%/26% and 20%/22%, respectively). The pre-planned secondary outcome, indigestion, was improved at four weeks (32%) but compared to the placebo (21%) was not significant (p = 0.079). Exploratory analysis, however, revealed that clusters for constipation (18% improvement, p < 0.001), indigestion (11% improvement, p = 0.04), and dyspepsia (10% improvement, p = 0.04) were significantly improved in the intervention group compared to the placebo. Conclusions: These initial findings suggest that in people with self-reported FGID, BG01-4™ improves specific symptoms of constipation and related GI dysfunction. Longer-term confirmatory studies for this intervention are warranted. Trial registration: This study was registered prospectively (25 October 2021) at the Australian New Zealand Clinical Trials Registry (ACTRN12621001441808p).
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