Fecal microbiota transplant for children with autism
Study Protocol for a Randomized Controlled of Fecal Microbiota Transplantation Via Different Routes in Children With Moderate-to-Severe Autism Spectrum Disorder
This trial will test whether transplanting healthy gut bacteria through a tube placed past the stomach (nasojejunal) or via colonoscopy helps behavior and gut symptoms in children aged 3–16 with moderate-to-severe autism.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1 (estimated) |
| Ages | 3 Years to 16 Years |
| Sex | All |
| Sponsor | Shenzhen Children's Hospital Government |
| Locations | 1 site (Shenzhen, Guangdong) |
| Trial ID | NCT07381374 on ClinicalTrials.gov |
What this trial studies
This single-center, randomized, double-dummy, triple-blind, placebo-controlled trial will enroll 75 children (3–16 years) with DSM-5–confirmed moderate-to-severe ASD and randomize them 1:1:1 to FMT via nasojejunal tube, FMT via colonoscopy with a transendoscopic tube, or placebo procedures. Participants will continue stable behavioral interventions and receive repeated infusions (5 mL/kg, max 100 mL) with safety and clinical follow-up through 48 weeks. The primary outcome is change in the Childhood Autism Rating Scale (CARS) from baseline to Week 24, and secondary outcomes include measures of social responsiveness, aberrant behavior, sensory processing, sleep, GI symptoms, and gut microbiota profiling. Sham procedures are used to maintain blinding while comparing upper- versus lower-gut delivery routes for microbiota engraftment and clinical effect.
Who should consider this trial
Good fit: Children aged 3–16 with DSM-5–diagnosed moderate-to-severe ASD (CARS ≥36), able to comply with visits and not having used probiotics within 3 months or antibiotics within 1 month, are the intended participants.
Not a fit: Children with mild ASD, recent probiotic or antibiotic use, severe active gastrointestinal disease, dependency on tube feeding, or fever are unlikely to benefit or are excluded from participation.
Why it matters
Potential benefit: If effective, the treatment could reduce autism-related behavioral symptoms and improve gastrointestinal complaints in affected children.
How similar studies have performed: Small open-label and uncontrolled FMT reports in ASD have suggested behavioral and GI improvements, but high-quality randomized, blinded comparisons remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shenzhen, Guangdong
- Children's Hospital, Shenzhen — Shenzhen, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Dongling Dai, PhD
- Email: daidong3529@email.szu.edu.cn
- Phone: 08618938690736
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.