Evidence map›Paper›PMID 42782450›Full record

ArticleAdvances in therapy2026

Acute Tolerability and Long-Term Surveillance of Fecal Microbiota Transplantation in Children with Autism: A Real-World Study of 604 Procedures.

Youran Li, Wenwen Yu, Rulan Liu, Pei Xiao, Xiaolu Li, Ting Zhang

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Article in Advances in therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

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2 · The registry

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5 · Who and what money

Authors and funding

6 authors.

Youran LiDepartment of Gastroenterology, Hepatology and Nutrition, Shanghai Children's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, 200062, China.ORCID http://orcid.org/0000-0002-2993-8516
Wenwen YuDepartment of Gastroenterology, Hepatology and Nutrition, Shanghai Children's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, 200062, China.
Rulan LiuDepartment of Gastroenterology, Hepatology and Nutrition, Shanghai Children's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, 200062, China.
Pei XiaoDepartment of Gastroenterology, Hepatology and Nutrition, Shanghai Children's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, 200062, China.
Xiaolu LiDepartment of Gastroenterology, Hepatology and Nutrition, Shanghai Children's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, 200062, China.
Ting ZhangDepartment of Gastroenterology, Hepatology and Nutrition, Shanghai Children's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, 200062, China. zhangt@shchildren.com.cn.

Funding

Shanghai Municipal Health Commission 20244Y0090
6 · The paper itself

Abstract

introductionFecal microbiota transplantation (FMT) is a promising adjunctive therapy for autism spectrum disorder (ASD), yet comprehensive, real-world safety data in pediatric populations remain limited. This study aimed to systematically evaluate the safety profile, temporal kinetics, and risk factors for adverse events (AEs) following FMT in children with ASD.

methodsWe conducted a longitudinal observational study of 224 children with ASD (aged 2-17 years) who underwent a total of 604 FMT procedures. Interventions were administered via oral capsules (Caps), nasojejunal tube (NJT), or transendoscopic enteral tube (TET). AEs were systematically graded using common terminology criteria for AEs (CTCAE) criteria, and a multivariate generalized estimating equations (GEE) model was used to identify independent risk factors.

resultsIn our study, the overall incidence of AEs across 604 procedures was low at 2.5% (15/604 procedures). All documented AEs had an acute onset (< 48 h post-procedure), were strictly Grade 1 (mild) in severity, and spontaneously resolved (median duration 28.0 h). The most frequent symptoms were vomiting and irritability, with no severe or long-term AEs observed. Delivery route significantly impacted safety, and TET exhibited the highest AE rate (26.3%), whereas Caps (1.7%) and NJT (1.8%) demonstrated favorable tolerability. Multivariate analysis identified TET as the independent risk factor for AEs (adjusted odds ratio 21.90, P < 0.001).

conclusionFMT demonstrates favorable acute tolerability in children with ASD, with long-term longitudinal surveillance showing no delayed adverse outcomes. Oral capsules are associated with a low AE rate and represent a preferred delivery route.

trial registrationChinese Clinical Trial Registry, ChiCTR2200055943. Registered 28 January 2022, http://www.chictr.org.cn .

Indexed as

AutismFecal microbiota transplantationSafety

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.