Autism spectrum disorder
Conditions
Interventions
treatment group 1:whole intestinal microbiota transplantation
treatment group 2:Fecal microbiota transplantation
control group:Follow-up visit
Sponsors
Department of Pediatrics, Shanghai Tenth People’s Hospital
Eligibility
Sex/Gender
All
Age
3 Years to 14 Years
Inclusion criteria
Inclusion criteria: (1) Age 3-14 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 severe malnutrition (7) There is a planned use of probiotics and antibiotics in the past 3 months or in the next 6 months drugs that sound intestinal flora; (8) Have received FMT treatment in the past 12 months; (9) Do not swallow 3# capsules
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diversity and richness of flora; | — |
Secondary
| Measure | Time frame |
|---|---|
| Childhood Autism Rating Scale;Autism Behavior Checklist;Bristol Stool Form Scale;Gastrointestinal Symptom Rating Scale;Metabolic profile; | — |
Countries
China
Contacts
Public ContactYang Rong
Department of Pediatrics, Shanghai Tenth People’s Hospital
Outcome results
None listed