PROFIT：一项前瞻性、随机、安慰剂对照的粪便微生物群移植治疗肝硬化的可行性试验：一项单盲试验的研究方案。
PROFIT, a PROspective, randomised placebo controlled feasibility trial of Faecal mIcrobiota Transplantation in cirrhosis: study protocol for a single-blinded trial.
机构信息
James Black Centre, School of Immunology & Microbial Sciences, Faculty of Life Sciences & Medicine, King's College London, London, UK.
Department of Microbiology, Guy's & St Thomas' NHS Foundation Trust, London, UK.
出版信息
BMJ Open. 2019 Feb 15;9(2):e023518. doi: 10.1136/bmjopen-2018-023518.
INTRODUCTION
Patients with advanced cirrhosis have enteric bacterial dysbiosis and translocation of bacteria and their products across the gut epithelial barrier. This culminates in systemic inflammation and endotoxaemia, inducing innate immune dysfunction which predisposes to infection, and development of complications such as bleeding, sepsis and hepatic encephalopathy. This feasibility study aims to assess the safety of administering faecal microbiota transplantion to patients with cirrhosis and explore the effect of the intervention on their prognosis by achieving restoration of a healthy gut microbiome.
METHODS AND ANALYSIS
A PROspective, randomised placebo controlled feasibility trial of Faecal mIcrobiota Transplantation is a single-centre, randomised, single-blinded, placebo-controlled study evaluating faecal microbiota transplantation (FMT) against placebo. Patients with advanced but stable cirrhosis with a Model for End-Stage Liver Disease score between 10 and 16 will be recruited. Twenty-four patients will be randomised to FMT plus standard of care (as per our institutional practice) and eight patients to placebo in a ratio of 3:1. Patients will be evaluated at baseline before the study intervention is administered and at 7, 30 and 90 days post-intervention to assess safety and adverse events. FMT/placebo will be administered into the jejunum within 7 days of baseline. The primary outcome measure will be safety and feasibility as assessed by recruitment rates, tolerability and safety of FMT treatment. Results will be disseminated via peer-reviewed journals and international conferences. The recruitment of the first patient occurred on 23 May 2018.
ETHICS AND DISSEMINATION
Research Ethics approval was given by the London South East Research Ethics committee (ref 17/LO/2081).
TRIAL REGISTRATION NUMBER
NCT02862249 and EudraCT 2017-003629-13.
简介
患有晚期肝硬化的患者存在肠道细菌失调以及细菌及其产物穿过肠道上皮屏障的易位。这最终导致全身炎症和内毒素血症，诱导先天免疫功能障碍，从而易感染，并发展出出血、败血症和肝性脑病等并发症。这项可行性研究旨在评估对肝硬化患者进行粪便微生物移植的安全性，并通过恢复健康的肠道微生物组来探索该干预对其预后的影响。
方法和分析
一项前瞻性、随机、安慰剂对照的粪便微生物移植可行性试验是一项单中心、随机、单盲、安慰剂对照研究，评估粪便微生物群移植（FMT）与安慰剂的效果。将招募患有晚期但稳定的肝硬化患者，其终末期肝病模型评分在 10 到 16 之间。将 24 名患者随机分为 FMT 加标准护理（按我们的机构实践）组和 8 名安慰剂组，比例为 3:1。患者将在基线时进行评估，在研究干预措施实施前和干预后 7、30 和 90 天进行评估，以评估安全性和不良事件。FMT/安慰剂将在基线后 7 天内注入空肠。主要观察指标将是通过招募率、FMT 治疗的耐受性和安全性评估安全性和可行性。结果将通过同行评议的期刊和国际会议进行传播。首位患者的招募于 2018 年 5 月 23 日进行。
伦理和传播
伦敦东南研究伦理委员会（参考 17/LO/2081）已批准该研究。
试验注册号
NCT02862249 和 EudraCT 2017-003629-13。
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