Autism Spectrum Disorder
Conditions
Interventions
Intervention group:Transplantation of intestinal bacteria
Control group:Placebo
Sponsors
The First Medical Center of PLA General Hospital
Eligibility
Sex/Gender
All
Age
3 Years to 6 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged 3-6 years, no gender limit; 2. Children with autism who meet the DSM-5 diagnostic criteria; 3. Not taking probiotics and other biological agents, immunosuppressants, antibiotics and other supplements within 1 month; 4. The subject and/or guardian sign informed consent, allowing the researcher to cooperate with the whole process of the clinical trial and collect clinical data and peripheral blood, saliva, urine and stool samples; 5. Subjects can swallow capsules by themselves.
Exclusion criteria
Exclusion criteria: 1. Secondary autism (with a clear cause, such as metabolic abnormalities, genetic diseases, etc.); 2. Fever (body temperature above 37.3?); 3. Severe gastrointestinal diseases requiring immediate treatment, such as intestinal obstruction, intestinal bleeding, and intestinal perforation; 4. Accompanied by severe immunodeficiency; 5. Have a history of severe allergies; 6. Severely malnourished or underweight children; 7. Those undergoing special diet treatment; 8. BMI greater than the 90th percentile of children of the same age and sex; 9. Children considered unsuitable for inclusion by other researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diversity and richness of intestinal flora; | — |
Secondary
| Measure | Time frame |
|---|---|
| Days of constipation or diarrhea;Gastrointestinal Symptom Rating Scale;Bristol Stool Trait Score;Detection of fecal and blood metagenomics and metabolomics;Childhood Autism Rating Scale;Social Responsiveness Scale;Autism Behavior Checklist;Self-Rating Anxiety Scale for patients' parents; | — |
Countries
China
Contacts
Public ContactYang Guang
The First Medical Center of PLA General Hospital
Outcome results
None listed