Actively Recruiting
Fecal Microbiota Transplantation in Children With ASD
Led by Shenzhen Children's Hospital · Updated on 2026-04-20
1
Participants Needed
1
Research Sites
55 weeks
Total Duration
On this page
Sponsors
S
Shenzhen Children's Hospital
Lead Sponsor
S
Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Fecal Microbiota Transplantation in Children With ASD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 3-16 years
- Diagnosed with Autism Spectrum Disorder according to DSM-5 with moderate-to-severe symptoms (CARS score 6)
- Legal guardians understand and provide written informed consent
- Willing and able to comply with follow-up visits, tests, and specimen collection
- Have not taken probiotic supplements within 3 months prior to enrollment
You will not qualify if you...
- Use of probiotics or prebiotics within 3 months before enrollment
- Antibiotic use within 1 month before enrollment
- Current fever with axillary temperature 637.5�B0C
- Dependence on tube feeding
- Severe gastrointestinal conditions needing urgent treatment (such as intestinal obstruction, perforation, bleeding, ulcerative colitis, Crohn's disease, celiac disease, or eosinophilic esophagitis)
- Severe malnutrition, underweight (BMI-for-age below 3rd percentile), or severe immune deficiency
- History of severe allergic reactions like anaphylaxis
- Presence of monogenic disorders (e.g., Fragile X syndrome, Rett syndrome)
- Other psychiatric disorders including depression, speech/language disorders, intellectual disability, ADHD, selective mutism, reactive attachment disorder, or childhood schizophrenia
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Children's Hospital, Shenzhen
Shenzhen, Guangdong, China, 518026
Actively Recruiting
Research Team
D
Dongling Dai, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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