UiT The Arctic University of Norway, Tromso, Troms, Norway.
Medical Department, University Hospital of North Norway, Harstad, Troms, Norway.
BMJ Open. 2024 Jun 10;14(6):e073275. doi: 10.1136/bmjopen-2023-073275.
The observed alteration of the intestinal microbiota in patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and the effect of transferring a healthy gut flora from a faecal donor using a faecal microbiota transplantation (FMT) will be explored in this trial.
This is a protocol for a randomised, double-blind, placebo-controlled, parallel-group, single-centre trial, with 12 months follow-up. 80 participants will be included and randomised (1:1:2) to either donor FMT (from two different donors) or placebo (autologous FMT). Participants will be included by the International Clinical Criteria for ME/CFS. The clinical measures of ME/CFS and disease activity include Modified DePaul Questionnaire, Fatigue Severity Scale (FSS), Hospital Anxiety and Depression Scale (HADS), 36-Item Short Form Health Survey (SF-36), ROMA IV criteria, Food Frequency Questionnaire, Repeatable Battery for the Assessment of Neuropsychological Status, heart rate variability testing and reports on the use of antibiotics and food supplements, as well as biobanking of blood, urine and faeces.The primary endpoint is proportion with treatment success in FSS score in donor versus autologous FMT group 3 months after treatment. Treatment success is defined as an FSS improvement of more than 1.2 points from baseline at 3 months after treatment. Adverse events will be registered throughout the study.
The Regional Committee for Medical Research Ethics Northern Norway has approved the study. The study has commenced in May 2019. Findings will be disseminated in international peer-reviewed journal(s), submitted to relevant conferences, and trial participants will be informed via phone calls.
NCT03691987.
本试验旨在研究肌痛性脑脊髓炎/慢性疲劳综合征（ME/CFS）患者肠道微生物群的变化，以及通过粪便微生物群移植（FMT）将健康的肠道菌群从供体转移到患者体内的效果。
这是一项随机、双盲、安慰剂对照、平行组、单中心试验，随访时间为 12 个月。将纳入 80 名参与者，并按 1:1:2 的比例随机分为供体 FMT（来自两个不同的供体）或安慰剂（自体 FMT）组。参与者将按照 ME/CFS 的国际临床标准纳入。ME/CFS 和疾病活动的临床测量包括改良的德保罗问卷、疲劳严重程度量表（FSS）、医院焦虑和抑郁量表（HADS）、36 项简短健康调查问卷（SF-36）、ROMA IV 标准、食物频率问卷、重复认知状态评估测试、心率变异性测试以及抗生素和食物补充剂使用报告，以及血液、尿液和粪便的生物库。主要终点是治疗后 3 个月供体 FMT 组与自体 FMT 组 FSS 评分治疗成功的比例。治疗成功定义为治疗后 3 个月 FSS 评分较基线改善超过 1.2 分。整个研究期间将登记不良反应事件。
挪威北部地区医学研究伦理委员会已批准该研究。该研究已于 2019 年 5 月开始。研究结果将在国际同行评议期刊上发表，提交给相关会议，并通过电话告知试验参与者。
NCT03691987。
