Autism
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Age range from 3 to 13 years old, regardless of gender; (2) Meets the diagnostic criteria for ASD in the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); (3) Accompanied by gastrointestinal symptoms such as diarrhea, constipation, bloating, and/or food allergies/intolerance, with symptoms occurring for at least 6 months and more symptoms occurring in the past 3 months; (4) The subject and/or guardian sign an informed consent form, agreeing that the researcher will cooperate throughout the clinical trial process and collect clinical data, peripheral blood, and fecal samples, and be able to cooperate in completing brain fMRI examinations;
Exclusion criteria
Exclusion criteria: (1) Clear diagnosis of Rhett's syndrome (2) Clear history of organic brain diseases such as traumatic brain injury, cerebral palsy, and encephalitis (3) Individuals diagnosed with other mental illnesses (4) Existence of intestinal organic lesions such as congenital megacolon, intestinal obstruction, intussusception, etc (5) There are pathological changes in intestinal inflammation, such as inflammatory bowel disease, etc (6) Severe obesity or severe malnutrition (7) Planned use of probiotics, antibiotics, and other drugs that clearly affect gut microbiota within the past 3 months or within the next 6 months (8) Received FMT treatment within the past 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ABC scale;CARS scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| lymphocyte;cytokines; | — |
Countries
China
Contacts
Shanghai Tenth People's Hospital