NCT06290258 Fecal Microbiota Transplantation for Patients With Autism Spectrum Disorder.
| NCT ID | NCT06290258 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Chang Gung Memorial Hospital |
| Condition | Autism Spectrum Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-03-06 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2024-03-06 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Wei-Chih Chin
PRINCIPAL INVESTIGATOR
Chang Gung Medical Foundation
Frequently Asked Questions
Who can join the NCT06290258 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, up to 30 Years, studying Autism Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06290258 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06290258 currently recruiting?
Yes, NCT06290258 is actively recruiting participants. Contact the research team at auaug0327@cgmh.org.tw for enrollment information.
Where is the NCT06290258 trial being conducted?
This trial is being conducted at Taoyuan City, Taiwan.
Who is sponsoring the NCT06290258 clinical trial?
NCT06290258 is sponsored by Chang Gung Memorial Hospital. The principal investigator is Wei-Chih Chin at Chang Gung Medical Foundation. The trial plans to enroll 60 participants.