Fecal Microbiota Transplantation for Patients With Autism Spectrum Disorder.
Recruiting now · Phase 1/Phase 2
Conditions studied: Autism Spectrum Disorder, Gastrointestinal Diseases, Healthy
In brief
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.
Key facts
- Study ID
- NCT06290258
- Run by
- Chang Gung Memorial Hospital
- People needed
- 60
- Starts
- 2024-03-06
- Expected to finish
- 2027-07-31
- Last updated by the study team
- 2026-03-20
Who can join
Age: 7 and older, up to 30. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Diagnosed by a child psychiatrist in line with DSM-5 Autism Spectrum Disorder
- Combined with gastrointestinal problems, any Gastrointestinal Symptoms Rating Scale score≧3.
- Age is between 7-30.
- Participants who are willing to participate in the study and sign the informed consent.
You may not qualify if…
- Cases where clinical assessment cannot cooperate with fecal microbiota transplantation and examination.
- Cases requiring antibiotics within 3 months before or after acceptance because of their physiological condition.
- Cases requiring long-term use of proton pump inhibitors due to their physiological conditions.
- Severe physical diseases, such as acute gastrointestinal diseases, severe malnutrition or underweight, immunodeficiency diseases, severe allergies or autoimmune diseases, brain injuries or severe organic brain diseases, will affect the evaluation of treatment results.
- Severe mental illness, such as schizophrenia, bipolar disorder, etc.
- Those who used probiotics one month before the case may affect the intestinal flora.
- Pregnancy.
- Cases that cannot understand the content of this research.
- Participants who are unwilling to participate in the study or refuse to sign the informed consent.
- Participants who are not suitable to include in this study, evaluate by PI or Co-PI.
Where it is running
- Wei-Chih Chin — Taoyuan City, Taiwan (enrolling)
Full record on ClinicalTrials.gov
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