STUDY PROTOCOL article
Front. Pediatr.
Sec. Pediatric Gastroenterology, Hepatology and Nutrition
Protocol for the Efficacy and Safety of Fecal Microbiota Transplantation in Children with Autism Spectrum Disorder: A Prospective Single-Center, Single-Arm Interventional Study
Provisionally accepted
Baixian Lin
Ziyuan LiZhongsheng Zhu
Yigui ZouHu ChenZeling ZhuangShiyun MengWenwen LiQinghua Yang
Dongling Dai*- Shenzhen Children's Hospital, Shenzhen, China
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Background: Autism spectrum disorder (ASD) is a neurodevelopmental condition affecting 0.7% of children around the world, with 90% experiencing comorbid gastrointestinal (GI) symptoms. Fecal microbiota transplantation (FMT) may modulate ASD symptoms via the microbiome-gut-brain axis (MGBA). Methods: This open-label single-arm trial enrolls 30 children (2-12 years) with moderate-to-severe ASD (CARSā„36). Participants receive 3 nasojejunal FMTs (5mL/kg) over 5 days. Primary outcomes: GI symptom improvement (GSRS) and ASD severity (CARS). Secondary outcomes: social responsiveness (SRS), aberrant behaviors (ABC), and gut microbiome changes assessed by metagenomic next-generation sequencing (mNGS).
Keywords: Autism Spectrum Disorder, fecal microbiota transplantation, Microbiome-gut-brainAxis, microbiome, Gastrointestinal symptoms, Microbiota dysbiosis, Clinical protocol
Received: 08 Aug 2025; Accepted: 03 Dec 2025.
Copyright: Ā© 2025 Lin, Li, Zhu, Zou, Chen, Zhuang, Meng, Li, Yang and Dai. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Dongling Dai
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