Autism spectrum disorder
Conditions
Interventions
child donor capsule trial group:child donor capsule
adult donor capsule trial group:adult donor capsule
Sponsors
Shanghai Tenth People's Hospital
Eligibility
Sex/Gender
All
Age
3 Years to 13 Years
Inclusion criteria
Inclusion criteria: (1) Age 3-13 years old, male or female; (2) Meeting the ASD diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) of the American Psychiatric Association; (3) Accompanied with diarrhea, constipation, abdominal distension and/or food allergy/intolerance for at least 6 months and above symptoms occurred in the last 3 months; (4) Subjects and/or guardians sign the informed consent, and agree that the researcher will cooperate with the whole process of the clinical trial and collect clinical data, blood, saliva, urine and feces samples; (5) Able to swallow 3# FMT capsules by themselves.
Exclusion criteria
Exclusion criteria: (1) Diagnosis of Rett syndrome. (2) Previous history of brain injury, cerebral palsy, encephalitis or other brain organic diseases; (3) Diagnosis of other mental diseases; (4) Diagnosis of intestinal organic diseases, such as congenital megacolon, intestinal obstruction, intussusception, inflammatory bowel disease and etc. (5)There are pathological intestinal inflammatory changes, such as inflammatory bowel disease ; (6)Severe obesity or malnutrition; (7) Using probiotics, antibiotics and other drugs affecting intestinal flora in a planned way within the last 3 months or next the following 6 months; (8) Having received FMT treatment in the past 12 months; (9) Unable to swallow 3# FMT capsules by themselves.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Childhood Autism Rating Scale score;Autism Behavior Checklist score;Bristol Stool Form Scale score;Gastrointestinal Symptom Rating Scale score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Diversity and richness of flora;Metabolic profile; | — |
Countries
China
Contacts
Public ContactYang Rong
Shanghai Tenth People's Hospital
Outcome results
None listed