Wei Jinying, Chen Jiayi, Fang Xiaohui, Liu Tianyu, Yuan Yanhan, Zhang Jinping
College of Food Science and Technology, Shanghai Ocean University, Shanghai, China.
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Front Microbiol. 2023 Aug 22;14:1236904. doi: 10.3389/fmicb.2023.1236904. eCollection 2023.
Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by deficits in social interaction, repetitive behavior and language impairment, and its worldwide prevalence has been found to be increasing annually in recent years. Till now, ASD is uncurable as its pathogenesis remains unknown. However, studies on both animals and humans have demonstrated that fecal microbiota transplantation (FMT) may ameliorate the symptoms of ASD, as well as gastrointestinal symptoms. Nonetheless, there is still no agreement regarding the optimal dosage or duration of FMT treatment for individuals with ASD.
This clinical study is a double-blind, randomized, interventional trial conducted at a single center. The aim is to investigate the safety and efficacy of a pediatric formulation of FMT for ASD. A total of 42 children between the ages of 3-9 with ASD will be randomly assigned in a 2:1 ratio to either an FMT treatment group ( = 28) or a placebo group ( = 14), forming cohort 1. Additionally, 30 healthy children of similar age and gender will be recruited as the control group (cohort 2). Cohort 1 will be assessed using a variety of scales, including the Autism Behavior Checklist, Childhood Autism Rating Scale, Social Responsiveness Scale, Gastrointestinal Symptom Rating Scale, Children's Sleep Habits Questionnaire, and Psychoeducational Profile (Third Edition). These assessments will evaluate the effectiveness of FMT in reducing core symptoms and comorbidities (such as gastrointestinal symptoms and sleep disturbances) in children with ASD. The study will use metagenomic and metabolomic sequencing to assess changes in the composition and structure of the intestinal flora and its metabolites in blood, urine, and feces following treatment. Furthermore, the study will evaluate the acceptability of the FMT formulation by participants' legal guardians and investigate differences in the intestinal flora and metabolism in the FMT group before and after treatment compared to 30 healthy children.
https://www.chictr.org.cn/, identifier ChiCTR2200058459.
自闭症谱系障碍（ASD）是一种神经发育障碍，其特征为社交互动缺陷、重复行为和语言障碍，近年来全球患病率呈逐年上升趋势。迄今为止，由于其发病机制尚不清楚，ASD无法治愈。然而，对动物和人类的研究均表明，粪便微生物群移植（FMT）可能改善ASD症状以及胃肠道症状。尽管如此，对于ASD患者FMT治疗的最佳剂量或疗程仍未达成共识。
本临床研究是在单一中心进行的双盲、随机、干预性试验。目的是研究儿童剂型FMT治疗ASD的安全性和有效性。42名年龄在3至9岁之间的ASD儿童将按2:1的比例随机分配至FMT治疗组（n = 28）或安慰剂组（n = 14），形成队列1。此外，将招募30名年龄和性别相似的健康儿童作为对照组（队列2）。队列1将使用多种量表进行评估，包括《自闭症行为量表》《儿童自闭症评定量表》《社会反应量表》《胃肠道症状评定量表》《儿童睡眠习惯问卷》和《心理教育档案（第三版）》。这些评估将评估FMT在减轻ASD儿童核心症状和合并症（如胃肠道症状和睡眠障碍）方面的有效性。该研究将使用宏基因组和代谢组测序来评估治疗后血液、尿液和粪便中肠道菌群的组成和结构及其代谢产物的变化。此外，该研究将评估参与者法定监护人对FMT制剂的可接受性，并调查FMT组治疗前后与30名健康儿童相比肠道菌群和代谢的差异。
