Fecal Microbiota Transplantation for Patients With Autism Spectrum Disorder. (NCT06290258) | Clinical Trial Compass
RecruitingPhase 1/2
Fecal Microbiota Transplantation for Patients With Autism Spectrum Disorder.
Taiwan60 participantsStarted 2024-03-06
Plain-language 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.
Who can participate
Age range
7 Years – 30 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes of gastrointestinal symptoms of patients with ASD after FMT
Timeframe: baseline and the 1-year follow-up
2
Changes of autistic symptoms of patients with ASD after FMT