FTACMT study protocol: a multicentre, double-blind, randomised, placebo-controlled trial of faecal microbiota transplantation for autism spectrum disorder
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 clin...
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2022-01-01
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| author | 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 |
| author_facet | 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 |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-2092822de3704322a338206222195841 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-01-01 |
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| spelling | doaj-art-2092822de3704322a3382062221958412025-02-02T17:30:14ZengBMJ Publishing GroupBMJ Open2044-60552022-01-0112110.1136/bmjopen-2021-051613FTACMT study protocol: a multicentre, double-blind, randomised, placebo-controlled trial of faecal microbiota transplantation for autism spectrum disorder 0Li Ling1Wei Wei2Li Lin3Li Ke4Ye Chen5Li Ning6Wang Yu7Zhang XinYang Rong8Zhang Xueying9Cui Jiaqu10Chen Qiyi11Qin Huanlong12Du Yasong13Zhao Xiaoxin14Lu Jubao15Lv Xiaoqiong16Ma Chunlian17Chen Shidong18Kuang Guifang19Zhao Dongmei20Fang Shuanfeng21Zhang Xujing22Yang Binrang23Wang Yanxia24Yuan Song25Zhou Xiang26Zhang Beihua27Jiang Lin28Ji Hong29Yan YinmeiYan PeihuaHuang LinshengZhang ShaoyiMa ChenhuanMiao YunLing WenqiGeng BojingFeng XueyingLi HuilinLiu LiyanWu WeijiaLi DexinJiang Qianru11 Kenya National Bureau of Statistics, Nairobi, Nairobi, Kenya2 Department of Medical Statistics, School of Public Health, Sun Yat-sen University, Guangzhou, ChinaDepartment of Rheumatology and Immunology, Tianjin Medical University General Hospital, Tianjin, ChinaAnhui Medical University Affiliated Provincial Hospital, hefei, China4 Center of Health Administration and Development Studies, Hubei University of Medicine, Shiyan, Hubei, China9 Department of Gastroenterology and Hepatology, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, ChinaEye Institute and Department of Ophthalmology, Eye & ENT Hospital, Fudan University, Shanghai, ChinaChild Healthcare Department, Shanghai Children’s Hospital, Shanghai, ChinaDepartment of Colorectal Diseases, Shanghai Tenth People’s Hospital, Shanghai, ChinaDepartment of Colorectal Diseases, Shanghai Tenth People’s Hospital, Shanghai, ChinaDepartment of Colorectal Diseases, Shanghai Tenth People’s Hospital, Shanghai, ChinaDepartment of Colorectal Diseases, Shanghai Tenth People’s Hospital, Shanghai, ChinaDepartment of Colorectal Diseases, Shanghai Tenth People’s Hospital, Shanghai, ChinaChild and Adolescent Psychiatry, Shanghai Mental Health Center, Shanghai, ChinaChild and Adolescent Psychiatry, Shanghai Mental Health Center, Shanghai, ChinaDepartment of Colorectal Diseases, Shanghai Tenth People’s Hospital, Shanghai, ChinaDepartment of Colorectal Diseases, Shanghai Tenth People’s Hospital, Shanghai, ChinaDepartment of Colorectal Diseases, Shanghai Tenth People’s Hospital, Shanghai, ChinaRehabilitation Medicine Department, Shanghai First People’s Hospital, Shanghai, ChinaDepartment of Pediatric Mental Health, Qingdao Women and Children’s Hospital, Qingdao, ChinaInstitute of Child Health, Qilu Children’s Hospital of Shandong University, Jinan, ChinaChild Healthcare Department, Zhengzhou University Third Hospital and Henan Province Women and Children’s Hospital, Zhengzhou, ChinaClinical Psychology, Hebei Mental Health Center, Baoding, ChinaChild Healthcare Department, Shenzhen Children’s Hospital, Shenzhen, ChinaChild Healthcare Department, The Affiliated Hospital of Qingdao University, Qingdao, ChinaPsychiatry Department, Zhoushan Second People’s Hospital, Zhoushan, ChinaDepartment of Children Psychology, Zhuhai Maternal and Child Health Care Hospital, Zhuhai, ChinaYangzhi Affiliated Rehabilitation Hospital of Tongji University, Shanghai, ChinaPsychiatry Department, Dalian Seveth People’s Hospital, Dalian, ChinaWuhu No.1 People’s Hospital, Anhui, ChinaIntroduction 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.https://bmjopen.bmj.com/content/12/1/e051613.full |
| spellingShingle | 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 FTACMT study protocol: a multicentre, double-blind, randomised, placebo-controlled trial of faecal microbiota transplantation for autism spectrum disorder BMJ Open |
| title | FTACMT study protocol: a multicentre, double-blind, randomised, placebo-controlled trial of faecal microbiota transplantation for autism spectrum disorder |
| title_full | FTACMT study protocol: a multicentre, double-blind, randomised, placebo-controlled trial of faecal microbiota transplantation for autism spectrum disorder |
| title_fullStr | FTACMT study protocol: a multicentre, double-blind, randomised, placebo-controlled trial of faecal microbiota transplantation for autism spectrum disorder |
| title_full_unstemmed | FTACMT study protocol: a multicentre, double-blind, randomised, placebo-controlled trial of faecal microbiota transplantation for autism spectrum disorder |
| title_short | FTACMT study protocol: a multicentre, double-blind, randomised, placebo-controlled trial of faecal microbiota transplantation for autism spectrum disorder |
| title_sort | ftacmt study protocol a multicentre double blind randomised placebo controlled trial of faecal microbiota transplantation for autism spectrum disorder |
| url | https://bmjopen.bmj.com/content/12/1/e051613.full |
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