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RECRUITING
NCT06290258
PHASE1/PHASE2

Fecal Microbiota Transplantation for Patients With Autism Spectrum Disorder.

Sponsor: Chang Gung Memorial Hospital

View on ClinicalTrials.gov

Summary

This study aims to evaluate the efficacy of fecal microbiota transplantation on the gastrointestinal symptoms, autistic symptoms and emotional behavior symptoms of patients with autism spectrum disorder, and investigate the relations between the brain-gut axis, cytokines and autism spectrum disorder. Fecal microbiota transplantation have the potentials to improve intestinal microbiota composition, regulate immunity, and then improve gastrointestinal symptoms, autistic symptoms, emotional behavior symptoms and sleep of children with autism spectrum disorder. Early intervention at school-age may even benefit development, improve cognition and prognosis.

Official title: Fecal Microbiota Transplantation for Gastrointestinal, Autistic, Emotion, and Behavior Symptoms of Patients With Autism Spectrum Disorder and Gastrointestinal Problems: a Preliminary Study.

Key Details

Gender

All

Age Range

7 Years - 30 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-03-06

Completion Date

2027-07-31

Last Updated

2026-03-20

Healthy Volunteers

Yes

Interventions

PROCEDURE

Fecal microbiota transplantation

Fecal microbiota transplantation has been applied to patients with autism spectrum disorder in recent years. Fecal microbiota of healthy donors can be transplanted to patients through colonoscopy. Before donation, donors were comprehensively screened to rule out gastrointestinal symptoms and infections. Patients will receive colon preparation before transplantation. After the intervention, patients will have to stay in bed and be monitored for 24 hours to assure safety.

Locations (1)

Wei-Chih Chin

Taoyuan, Taiwan