Autism Spectrum Disorder
Conditions
Interventions
Intervention group:FMT-MLSC
Sponsors
Shanghai Tenth People's Hospital
Eligibility
Sex/Gender
All
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: (1)Aged 2 to 17 years, 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)Informed consent was signed by the subjects and/or guardians, and clinical data and blood, saliva, urine and feces samples were collected throughout the clinical trial; (5)Able to swallow the multi-layer seamless capsules by themselves.
Exclusion criteria
Exclusion criteria: (1)The diagnosis was Reiter's 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 severe malnutrition; (7)Using probiotics, antibiotics and other drugs affecting intestinal flora in a planned way within the last 3 months or in the following 6 months; (8)Have received FMT treatment in the last 12 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Autism Behavior Checklist;Childhood Autism Rating Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bristol Stool Form Scale;Gastrointestinal Symptom Rating Scale;Structure of gut microbiome; | — |
Countries
China
Contacts
Public ContactChen Qiyi
Shanghai Tenth People's Hospital
Outcome results
None listed