Dataset Information

FTACMT study protocol: a multicentre, double-blind, randomised, placebo-controlled trial of faecal microbiota transplantation for autism spectrum disorder.

ABSTRACT:

Introduction

Autism spectrum disorder (ASD) is a complicated diffuse developmental disorder that commonly involves gastrointestinal distress and dysbacteriosis. Emerging lines of evidence have shown faecal microbiota transplantation (FMT) to be a potential therapeutic strategy for improving the clinical outcomes of patients with ASD by re-establishing their intestinal microflora. We are undertaking the first-ever multicentre, double-blind, randomised controlled trial of FMT for the treatment of children with both ASD and gastrointestinal symptoms and will assess the feasibility and efficacy outcomes of this strategy.

Methods

In total, 318 children with both ASD and gastrointestinal symptoms will be enrolled (from 15 hospitals in China) to receive either FMT intervention (n=212) or a placebo (control, n=106). Children aged 3-6 years will take two capsules two times a day, and those older than 6 years will take three capsules two times a day. Each patient will receive four treatment courses, with each 12-day course being repeated every month. Outcomes will be evaluated at baseline, throughout the period of intervention, and at subsequent follow-ups for 2 months. The primary trial objective is to investigate the remodelling effect of FMT on the intestinal microflora in patients with ASD. The secondary objective focuses on the clinical efficacy and safety of FMT, including its improvement of the clinical response and metabonomics.

Ethics and dissemination

Ethical approval was obtained from the hospital Ethics Committee of each Faecal Transfer for ASD China Multicenter Trial Working Group. The ongoing FMT clinical trial is intended to support the approval of the new technology and its administration. The results of this trial will provide high-quality evidence to inform the future clinical application of this new therapy.

Trial registration number

ChiCTR2100043906; Pre-results.

SUBMITTER: Chen Y

PROVIDER: S-EPMC8804636 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature

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Publications

FTACMT study protocol: a multicentre, double-blind, randomised, placebo-controlled trial of faecal microbiota transplantation for autism spectrum disorder.

Chen Ye Y Xueying Zhang Z Jiaqu Cui C Qiyi Chen C Huanlong Qin Q Ning Li L Yasong Du D Xiaoxin Zhao Z Rong Yang Y Jubao Lu L Xiaoqiong Lv L Chunlian Ma M Yu Wang W Shidong Chen C Guifang Kuang K Dongmei Zhao Z Shuanfeng Fang F Xujing Zhang Z Binrang Yang Y Yanxia Wang W Ling Li L Song Yuan Y Xiang Zhou Z Beihua Zhang Z Lin Jiang J Hong Ji J

BMJ open 20220131 1

<h4>Introduction</h4>Autism spectrum disorder (ASD) is a complicated diffuse developmental disorder that commonly involves gastrointestinal distress and dysbacteriosis. Emerging lines of evidence have shown faecal microbiota transplantation (FMT) to be a potential therapeutic strategy for improving the clinical outcomes of patients with ASD by re-establishing their intestinal microflora. We are undertaking the first-ever multicentre, double-blind, randomised controlled trial of FMT for the treat ...[more]

PMID: 35105621

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Dataset Information

FTACMT study protocol: a multicentre, double-blind, randomised, placebo-controlled trial of faecal microbiota transplantation for autism spectrum disorder.

Introduction

Methods

Ethics and dissemination

Trial registration number

Publications

FTACMT study protocol: a multicentre, double-blind, randomised, placebo-controlled trial of faecal microbiota transplantation for autism spectrum disorder.

Similar Datasets

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