RecruitingNot Applicable

Fecal Microbiota Transplantation in Children With ASD

China1 participantsStarted 2026-03-21

Plain-language summary

This is a single-center, randomized, double-dummy, triple-blind, placebo-controlled, three-arm parallel-group superiority trial. The study aims to compare the efficacy and safety of Fecal Microbiota Transplantation (FMT) administered via two different invasive routes-nasojejunal tube (NJT) and colonoscopy-versus a placebo control in children aged 3-16 years with moderate-to-severe Autism Spectrum Disorder (ASD). A total of 75 participants will be randomized in a 1:1:1 ratio to receive either active FMT via NJT with sham colonoscopy, active FMT via colonoscopy with sham NJT, or placebo via both routes. All participants will continue their stable behavioral interventions throughout the study. The primary outcome is the change from baseline to Week 24 in the total score of the Childhood Autism Rating Scale (CARS). Secondary outcomes include changes in other behavioral and gastrointestinal symptom scores, gut microbiota profiling, and safety assessments over 48 weeks.

Who can participate

Age range

3 Years – 16 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: * Aged 3-16 years. * Diagnosed with ASD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), with a Childhood Autism Rating Scale (CARS) total score ≥36 (moderate-to-severe autism). * Legal guardians fully comprehend the trial's informed consent and voluntarily provide written consent. * Compliance with follow-up visits, examinations, and specimen collection. * No probiotic supplements consumed within the preceding 3 months. Exclusion Criteria: * Use of probiotics or prebiotics within 3 months prior to enrollment. * Antibiotic usage within 1 month prior to enrollment. * Presence of fever (axillary temperature ≥37.5°C). * Dependency on tube feeding. * Severe gastrointestinal conditions requiring immediate intervention (e.g., life-threatening intestinal obstruction, perforation, hemorrhage, ulcerative colitis, Crohn's disease, celiac disease, or eosinophilic esophagitis). * Diagnosis of severe malnutrition, underweight status (BMI-for-age \<3rd percentile), or severe immunodeficiency disorders. * History of severe allergic reactions (e.g., anaphylaxis). * Monogenic disorders (e.g., Fragile X syndrome, Rett syndrome). * Comorbid psychiatric diagnoses, including depression, developmental speech/language disorders, intellectual disability, attention-deficit/hyperactivity disorder (ADHD), selective mutism, reactive attachment disorder, or childhood schizophrenia.

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

Change in Total Score on the Childhood Autism Rating Scale (CARS)

Timeframe: Pre-FMT, 3 months post-FMT, and 6 months post-FMT

Trial details

NCT IDNCT07381374

SponsorShenzhen Children's Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Dongling Dai, PhD

08618938690736 daidong3529@email.szu.edu.cn

View on ClinicalTrials.gov More Autism Spectrum Disorder trials