Fecal Microbiota Transplantation in Children With ASD

This is a single-center, randomized, double-dummy, triple-blind, placebo-controlled, three-arm parallel-group superiority trial. The study aims to compare the efficacy and safety of Fecal Microbiota Transplantation (FMT) administered via two different invasive routes-nasojejunal tube (NJT) and colonoscopy-versus a placebo control in children aged 3-16 years with moderate-to-severe Autism Spectrum Disorder (ASD). A total of 75 participants will be randomized in a 1:1:1 ratio to receive either active FMT via NJT with sham colonoscopy, active FMT via colonoscopy with sham NJT, or placebo via both routes. All participants will continue their stable behavioral interventions throughout the study. The primary outcome is the change from baseline to Week 24 in the total score of the Childhood Autism Rating Scale (CARS). Secondary outcomes include changes in other behavioral and gastrointestinal symptom scores, gut microbiota profiling, and safety assessments over 48 weeks.

NCT Number	NCT07381374
Lead Sponsor	Shenzhen Children's Hospital Collaborators: Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences, Shenzhen Medical Academy of Research and Translation
Conditions	Autism Spectrum Disorder
Enrollment	1 participants
Start Date	2026-03-21
Primary Completion	2026-12-31 (estimated)
Study Completion	2027-04-12 (estimated)
Updated on ClinicalTrials.gov	2026-06-09