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Fecal Microbiota Transplantation for Patients With Autism Spectrum Disorder.

NCT06290258 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-03-20

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Wei-Chih Chin · Chang Gung Medical Foundation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-06
Primary Completion
2027-07-31
Completion
2027-07-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06290258 on ClinicalTrials.gov