Autism spectrum disorder
Conditions
Interventions
Intervention group:Oral probiotics (ingredients: Lactobacillus reuteri lr99, Lactobacillus rhamnosus GG, Lactobacillus plantarum lp139, Lactobacillus helveticus r0052, Isomaltooligosaccharides, inulin
Sponsors
Suzhou Municipal Hospital
Eligibility
Sex/Gender
All
Age
2 Years to 6 Years
Inclusion criteria
Inclusion criteria: 1. Aged 2 years or older, but less than (or equal to) 6 years old; 2. Diagnosed with ASD by two pediatric developmental-behavioral specialists or child psychiatrists through clinical evaluation, based on the DSM-5 criteria; 3. CARS score >= 35 points; 4. 6-GSI >= 4 points; 5. Guardian understands and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. History of other neurological or organic brain diseases, including but not limited to epilepsy, cerebral palsy, encephalitis (acute phase), tumors, etc.; 2. History of birth asphyxia, severe premature birth, or perinatal injury; 3. Presence of other serious physical diseases such as congenital heart disease, congenital arrhythmia, ulcerative colitis, Crohn's disease, malignant tumors, intestinal obstruction, severe immune diseases, etc.; 4. Long-term use of additional nutritional supplements, such as large amounts of probiotics or prebiotics; 5. Use of antibiotics, microbiota regulators, or antifungal drugs within 1 month before sampling; 6. Use of antidepressants, anxiolytics, or antipsychotic drugs within 3 months before sampling; 7. Received FMT treatment within the past 12 months; 8. Participation in other clinical trials within 1 month before selection (excluding those who failed screening and did not enroll); 9. History of allergy to any component of the trial product or similar drugs, or having an allergic constitution (allergic to two or more drugs or foods) and judged by the investigator as unsuitable for participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of 6-GSI score ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Alpha diversity of gut microbiota;Change of ADOS score ; | — |
Countries
China
Contacts
Public ContactWei Ran
Suzhou Municipal Hospital
Outcome results
None listed