Autism spectrum disorder
Conditions
Interventions
Control group:Continue existing therapies
FMT group:Fecal microbiota transplantation (FMT) plus existing therapies
Sponsors
Shanghai Deji Hospital
Eligibility
Sex/Gender
All
Age
3 Years to 14 Years
Inclusion criteria
Inclusion criteria: 1. Inclusion criteria: Age = 30; Autism Behavior Checklist (ABC) total score >= 67. 3. Legal guardian must provide signed informed consent for clinical data collection and biospecimen sampling (e.g., peripheral blood, fecal samples).
Exclusion criteria
Exclusion criteria: 1. Known allergy to any component of the investigational drug; 2. Confirmed diagnosis of Rett syndrome (RTT); 3. History of organic brain diseases (e.g., traumatic brain injury, cerebral palsy, encephalitis); 4. Use of medications affecting gut microbiota (e.g., probiotics, antibiotics, acid suppressants) within the past week; 5. Presence of gastrointestinal organic pathologies (e.g., Hirschsprung's disease, intestinal obstruction, intussusception) or genetic disorders associated with developmental abnormalities; 6. Developmental Quotient (DQ) score <35; 7. Concurrent participation in other clinical trials that may interfere with outcome assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ASD symptoms; | — |
Secondary
| Measure | Time frame |
|---|---|
| Gastrointestinal symptoms;Gut microbiota status; | — |
Countries
China
Contacts
Public ContactChen Yucai
Shanghai Deji Hospital
Outcome results
None listed