Autism spectrum disorder
Conditions
Interventions
Intervention group:IJT capsules and FMT capsules
Control group:FMT capsules
Sponsors
Department of Colorectal Disease, the Tenth People's Hospital, Tongji University
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) The subject's guardian should be matched with the donor screening criteria of Expert consensus on the establishment of standardized methodology and clinical application for FMT, and sign the informed consent, agreeing to perform the nasojejunal tube implantation and collect intestinal juice. The intestinal juice will be made into IJT capsules, which will be used for his/her child. The child and guardian should also be cooperated with the whole process of the clinical trial and be collected 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) Using probiotics, antibiotics and other drugs affecting intestinal flora in a planned way within the last 3 months or in the following 6 months; (7) The guardian does not consent to nor is unable to perform the nasojejunal tube implantation, nor the guardian does not meet the donor screening criteria.
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 ContactQin Huanlong
Department of Colorectal Disease, Shanghai Tenth People's Hospital
Outcome results
None listed