Alaeddin Sara, Ko Yanna, Steiner-Lim Genevieve Z, Jensen Slade O, Roberts Tara L, Ho Vincent
School of Medicine, Western Sydney University, Penrith 2751, Australia.
NICM Health Research Institute and Translational Health Research Institute (THRI), Western Sydney University, Westmead 2145, Australia.
Methods Protoc. 2025 Aug 1;8(4):83. doi: 10.3390/mps8040083.
Faecal microbiota transplantation (FMT) is an emerging therapy for gastrointestinal and neurological disorders, acting via the microbiota-gut-brain axis. Altering gut microbial composition may influence cognitive function, but this has not been tested in cognitively healthy adults. This randomised, double-blinded, placebo-controlled pilot trial investigates whether FMT is feasible and improves cognition in adults with irritable bowel syndrome (IBS). Participants receive a single dose of FMT or placebo via rectal retention enema. Cognitive performance is the primary outcome, assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB). Secondary outcomes include IBS symptom severity and mood. Tertiary outcomes include microbiome composition and plasma biomarkers related to inflammation, short-chain fatty acids, and tryptophan metabolism. Outcomes are assessed at baseline and at one, three, six, and twelve months following treatment. We hypothesise that FMT will lead to greater improvements in cognitive performance than placebo, with benefits extending beyond practice effects, emerging at one month and persisting in the long term. The findings will contribute to evaluating the safety and efficacy of FMT and enhance our understanding of gut-brain interactions.
粪便微生物群移植(FMT)是一种针对胃肠道和神经系统疾病的新兴疗法,通过微生物群-肠-脑轴发挥作用。改变肠道微生物组成可能会影响认知功能,但这尚未在认知健康的成年人中得到验证。这项随机、双盲、安慰剂对照的试点试验旨在研究FMT对肠易激综合征(IBS)成人患者是否可行以及是否能改善认知。参与者通过直肠保留灌肠接受单剂量FMT或安慰剂。认知表现是主要结局,使用剑桥神经心理测试自动成套系统(CANTAB)进行评估。次要结局包括IBS症状严重程度和情绪。三级结局包括微生物群组成以及与炎症、短链脂肪酸和色氨酸代谢相关的血浆生物标志物。在基线以及治疗后的1个月、3个月、6个月和12个月对结局进行评估。我们假设,与安慰剂相比,FMT将使认知表现得到更大改善,其益处不仅限于练习效应,在1个月时出现并长期持续。这些发现将有助于评估FMT的安全性和有效性,并增进我们对肠-脑相互作用的理解。
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