Autism Spectrum disorder
Conditions
Interventions
Pre-FMT treatment group:None
post-FMT treatment group:FMT Capsules
Sponsors
Suzhou Municipal Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 3-13 years, any gender; 2. Meet the diagnostic criteria for ASD in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) by the American Psychiatric Association; 3. Accompanied by diarrhea, constipation, bloating, and/or food allergies/intolerances, with symptoms present for at least 6 months and episodes of the above symptoms occurring in the past 3 months; 4. The participant and/or guardian has signed the informed consent form, agreeing to cooperate with the entire clinical trial process and provide clinical data as well as peripheral blood, saliva, urine, and fecal samples; 5. Able to swallow a size 3 capsule independently.
Exclusion criteria
Exclusion criteria: 1. A clear diagnosis of other neurodevelopmental disorders, such as Rett syndrome, Fragile X syndrome, etc.; 2. A history of definite organic brain diseases such as traumatic brain injury, cerebral palsy, encephalitis, etc.; 3. A clear diagnosis of other mental disorders; 4. Presence of organic intestinal lesions such as congenital megacolon, intestinal obstruction, intussusception, etc.; 5. Presence of pathological intestinal inflammatory changes, such as inflammatory bowel disease; 6. Presence of severe systemic diseases, such as severe malnutrition, severe obesity, congenital heart disease, etc.; 7. Planning to use probiotics, antibiotics, or other drugs affecting gut microbiota within the past 3 months or in the next 6 months; 8. Have received FMT treatment within the past 12 months; 9. Unable to swallow size 3 capsules.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of ASD symptoms;Improvement of gastrointestinal symptoms;Blood routine; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in intestinal microbiota;Metabolomic alterations; | — |
Countries
China
Contacts
Public ContactHuanlong Qin
Suzhou Municipal Hospital
Outcome results
None listed