Autism
Conditions
Interventions
Intervention group:FMT and HIFT capsules
Sponsors
Shanghai Tenth People's Hospital
Eligibility
Sex/Gender
All
Age
3 Years to 13 Years
Inclusion criteria
Inclusion criteria: 1.Aged 3 to 13 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 peripheral blood, saliva, urine and feces samples were collected throughout the clinical trial; 5.Able to swallow 3# 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 |
|---|---|
| Childhood Autism Rating Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Autism Behavior Checklist;Bristol Stool Form Scale;Gastrointestinal Symptom Rating Scale;Patient Generated Index;Social Anxiety Scale for Children;Children's Depression Inventory; | — |
Countries
China
Contacts
Public ContactChen Qiyi
Shanghai Tenth People's Hospital
Outcome results
None listed