NCT06290258RecruitingPhase 1/2
Fecal Microbiota Transplantation for Patients With Autism Spectrum Disorder.
Fecal Microbiota Transplantation for Gastrointestinal, Autistic, Emotion, and Behavior Symptoms of Patients With Autism Spectrum Disorder and Gastrointestinal Problems: a Preliminary Study.
Source: ClinicalTrials.gov · Last updated 20 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 31 Jan 2024
- Start date
- 6 Mar 2024
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- Chang Gung Memorial Hospital
- Diseases
- Autism
- NCT number
- NCT06290258
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 60
- From 6 Mar 2024 to the primary completion date, 31 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Those who used probiotics one month before the case may affect the intestinal flora.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 7 years to 30 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wei-Chih Chin Coordinator of this site? Confirm its status | Taoyuan City | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.