FTACMT study protocol: a multicentre, double-blind, randomised, placebo-controlled trial of faecal microbiota transplantation for autism spectrum disorder
,
Li Ling,
Wei Wei,
Li Lin,
Li Ke,
Ye Chen,
Li Ning,
Wang Yu,
Zhang Xin,
Yang Rong,
Zhang Xueying,
Cui Jiaqu,
Chen Qiyi,
Qin Huanlong,
Du Yasong,
Zhao Xiaoxin,
Lu Jubao,
Lv Xiaoqiong,
Ma Chunlian,
Chen Shidong,
Kuang Guifang,
Zhao Dongmei,
Fang Shuanfeng,
Zhang Xujing,
Yang Binrang,
Wang Yanxia,
Yuan Song,
Zhou Xiang,
Zhang Beihua,
Jiang Lin,
Ji Hong,
Yan Yinmei,
Yan Peihua,
Huang Linsheng,
Zhang Shaoyi,
Ma Chenhuan,
Miao Yun,
Ling Wenqi,
Geng Bojing,
Feng Xueying,
Li Huilin,
Liu Liyan,
Wu Weijia,
Li Dexin,
Jiang Qianru
Affiliations
11 Kenya National Bureau of Statistics, Nairobi, Nairobi, Kenya
Li Ling
2 Department of Medical Statistics, School of Public Health, Sun Yat-sen University, Guangzhou, China
Wei Wei
Department of Rheumatology and Immunology, Tianjin Medical University General Hospital, Tianjin, China
Li Lin
Anhui Medical University Affiliated Provincial Hospital, hefei, China
Li Ke
4 Center of Health Administration and Development Studies, Hubei University of Medicine, Shiyan, Hubei, China
Ye Chen
9 Department of Gastroenterology and Hepatology, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China
Li Ning
Eye Institute and Department of Ophthalmology, Eye & ENT Hospital, Fudan University, Shanghai, China
Wang Yu
Child Healthcare Department, Shanghai Children’s Hospital, Shanghai, China
Zhang Xin
Yang Rong
Department of Colorectal Diseases, Shanghai Tenth People’s Hospital, Shanghai, China
Zhang Xueying
Department of Colorectal Diseases, Shanghai Tenth People’s Hospital, Shanghai, China
Cui Jiaqu
Department of Colorectal Diseases, Shanghai Tenth People’s Hospital, Shanghai, China
Chen Qiyi
Department of Colorectal Diseases, Shanghai Tenth People’s Hospital, Shanghai, China
Qin Huanlong
Department of Colorectal Diseases, Shanghai Tenth People’s Hospital, Shanghai, China
Du Yasong
Child and Adolescent Psychiatry, Shanghai Mental Health Center, Shanghai, China
Zhao Xiaoxin
Child and Adolescent Psychiatry, Shanghai Mental Health Center, Shanghai, China
Lu Jubao
Department of Colorectal Diseases, Shanghai Tenth People’s Hospital, Shanghai, China
Lv Xiaoqiong
Department of Colorectal Diseases, Shanghai Tenth People’s Hospital, Shanghai, China
Ma Chunlian
Department of Colorectal Diseases, Shanghai Tenth People’s Hospital, Shanghai, China
Chen Shidong
Rehabilitation Medicine Department, Shanghai First People’s Hospital, Shanghai, China
Kuang Guifang
Department of Pediatric Mental Health, Qingdao Women and Children’s Hospital, Qingdao, China
Zhao Dongmei
Institute of Child Health, Qilu Children’s Hospital of Shandong University, Jinan, China
Fang Shuanfeng
Child Healthcare Department, Zhengzhou University Third Hospital and Henan Province Women and Children’s Hospital, Zhengzhou, China
Zhang Xujing
Clinical Psychology, Hebei Mental Health Center, Baoding, China
Yang Binrang
Child Healthcare Department, Shenzhen Children’s Hospital, Shenzhen, China
Wang Yanxia
Child Healthcare Department, The Affiliated Hospital of Qingdao University, Qingdao, China
Yuan Song
Psychiatry Department, Zhoushan Second People’s Hospital, Zhoushan, China
Zhou Xiang
Department of Children Psychology, Zhuhai Maternal and Child Health Care Hospital, Zhuhai, China
Zhang Beihua
Yangzhi Affiliated Rehabilitation Hospital of Tongji University, Shanghai, China
Jiang Lin
Psychiatry Department, Dalian Seveth People’s Hospital, Dalian, China
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.
