School Allied Health, Human Services and Sport, Melbourne 3086, Australia.
Adepa Lifesciences, Melbourne 3000, Australia.
Nutrients. 2023 Oct 24;15(21):4490. doi: 10.3390/nu15214490.
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 (BG01-4™) high in branched-chain fatty acids (BCFA) to treat self-reported FGID.
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.
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 ( = 0.079). Exploratory analysis, however, revealed that clusters for constipation (18% improvement, < 0.001), indigestion (11% improvement, = 0.04), and dyspepsia (10% improvement, = 0.04) were significantly improved in the intervention group compared to the placebo.
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.
This study was registered prospectively (25 October 2021) at the Australian New Zealand Clinical Trials Registry (ACTRN12621001441808p).
功能性胃肠疾病（FGIDs）较为常见且难以治疗。益生菌作为一种影响胃肠道（GI）健康的饮食成分正在兴起。我们进行了一项双盲随机对照试验，研究了一种高支链脂肪酸（BCFA）的灭活专有菌株（BG01-4™）治疗自述 FGID 的效果。
67 名参与者（n=67）完成了为期四周的 BG01-4™（n=34）或安慰剂（n=33）干预。胃肠道症状评分量表（GSRS）作为主要结局指标，在干预完成前、两周和四周后进行收集。
在四周时，实验组的三个主要结局之一，便秘，与安慰剂相比改善了 33%（15%）；其他两个主要结局，总 GSRS 和腹泻，在实验组和安慰剂组均有显著改善（32%/26%和 20%/22%）。预先计划的次要结局，消化不良，在四周时得到改善（32%），但与安慰剂相比（21%）没有显著差异（=0.079）。然而，探索性分析显示，便秘（改善 18%，<0.001）、消化不良（改善 11%，=0.04）和消化不良（改善 10%，=0.04）的聚类在干预组中明显优于安慰剂组。
这些初步发现表明，在自述 FGID 的人群中，BG01-4™可改善便秘和相关 GI 功能障碍的特定症状。这种干预措施的长期确证研究是必要的。
这项研究于 2021 年 10 月 25 日在澳大利亚和新西兰临床试验注册中心（ACTRN12621001441808p）进行了前瞻性注册。
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