Autism spectrum disorder
Conditions
Interventions
Intestinal microecological reconstruction group:Fecal transplantation (by colonoscopy or oral fecal capsules)
Intestinal microecological reconstruction combined with gamma globulin treatment group:Fecal bacterial transplantation combined with intravenous infusion of gamma globulin
Gamma globulin treatment group:Intravenous gamma globulin
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
3 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. Aged 3-12 years, gender is not limited; 2. Diagnosed with autism spectrum disorder after assessment by ADOS and ADI-R; 3. Stop various antibiotics and other drugs that affect the gut microbiota; 4. The parents or legal guardians of the subjects have good reading and comprehension skills, and can cooperate with the completion of the relevant assessment scales and follow-up; 5. The parents or legal guardians of the subjects signed the informed consent in writing and voluntarily participated in this study.
Exclusion criteria
Exclusion criteria: 1. Coagulation disorders; 2. Intestinal obstruction, intestinal perforation, intestinal bleeding and other diseases that can cause serious systemic reactions due to intestinal microecological reconstruction; 3. Allergy to human immunoglobulin; 4. Selective IgA deficiency of anti-IgA antibodies; 5. In addition to autism spectrum disorder, there are other neurological, mental system diseases or serious physical diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Childhood Autism Rating Scale (CARS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Autism Behavior Checklist (ABC);Autism Diagnostic Interview-R (ADI- R);Autism Treatment Evaluation Checklist (ATEC);Gastrointestinal Symptom Rating Scale; | — |
Countries
China
Contacts
Public ContactYou Xin
Peking Union Medical College Hospital
Outcome results
None listed