NCT07381374Recruiting
Fecal Microbiota Transplantation in Children With ASD
Study Protocol for a Randomized Controlled of Fecal Microbiota Transplantation Via Different Routes in Children With Moderate-to-Severe Autism Spectrum Disorder
Source: ClinicalTrials.gov · Last updated 9 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1 (estimated)
- First submitted
- 25 Jan 2026
- Start date
- 21 Mar 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Shenzhen Children's Hospital
- Diseases
- Autism
- NCT number
- NCT07381374
What you commit to
- Study type: Interventional
- Planned participants: 1
- From 21 Mar 2026 to the primary completion date, 31 Dec 2026
- 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
- Use of probiotics or prebiotics within 3 months prior to enrollment.
- Antibiotic usage within 1 month prior to enrollment.
Other illness
- Severe gastrointestinal conditions requiring immediate intervention (e.g., life-threatening intestinal obstruction, perforation, hemorrhage, ulcerative colitis, Crohn's disease, celiac disease, or eosinophilic esophagitis).
- 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.
Age
- Diagnosis of severe malnutrition, underweight status (BMI-for-age \<3rd percentile), or severe immunodeficiency disorders.
Other
- Presence of fever (axillary temperature ≥37.5°C).
- Dependency on tube feeding.
Who the study is looking for
- 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.
Age in the registry: 3 years to 16 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Hospital, Shenzhen Coordinator of this site? Confirm its status | Shenzhen | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.