Autism Spectrum Disorder
Conditions
Interventions
treatment group:Interleukin-2 (IL-2), 16,000 IU/kg, added to 2.0ml sterile injection water, administered subcutaneously every other day. Treatment is administered in cycles of two weeks followed by a
placebo group:2.0ml sterile injection water, administered subcutaneously every other day. Treatment is administered in cycles of two weeks followed by a two-week rest period. A total of three treatmen
Sponsors
The Second Affiliated Hospital of Kunming Medical University
Eligibility
Sex/Gender
All
Age
3 Years to 16 Years
Inclusion criteria
Inclusion criteria: 1. Aged 3-16 years; 2. Diagnosis of ASD through the criteria of The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), the Autism Diagnostic Observation Scale (ADOS) and/or the Autism Diagnostic Interview Scale-Revised (ADI-R) ( ADI-R) to confirm the diagnosis of ASD; 3. Abnormalities in immunologic laboratory tests (meeting one of these criteria is sufficient): (1) The proportion of regulatory Treg cell subpopulation is = 2.44%; (4) Th2 lymphocyte subset >= 0.73%; (5) Th17 lymphocyte subpopulation >= 0.52%; (6) Tc1 lymphocyte subset >= 7.39%; (7) Th1/Treg ratio >= 0.63; (8) Th2/Treg ratio >= 0.17; (9) Peripheral blood cytokine TNF-a >= 2.49 pg/ml; (10) Peripheral blood cytokine IL-4 >= 5.29 pg/ml; (11) Peripheral blood cytokine IL-5 >= 2.81pg/ml; (12) Peripheral blood cytokine IL-17A >= 3.05 pg/ml; 4. No immunologic therapy within two weeks; 5. Subjects and parents signed informed consent.
Exclusion criteria
Exclusion criteria: 1. A history of other neurologic/psychiatric comorbidities such as seizures, schizophrenia, or substance abuse; 2. Those who have received relevant treatment prior to the study; 3. Those who have taken prescription antibiotics, yogurt or probiotic products, or have consumed medications with immunomodulatory properties within two weeks; 4. Allergy or hypersensitivity to IL-2 or similar products; 5. People with abnormal liver and kidney functions or people with combined liver and kidney underlying diseases; 6. Combined with hematologic diseases; 7. Combination of organic diseases; 8. Other conditions that the investigator considers unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sociological behavior score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunological index detection: T-lymphocyte subsets and other immunological indexes;Adverse reaction rate: such as injection reaction, vomiting, headache, etc; | — |
Countries
China
Contacts
Public ContactLin Zhao
The Second Affiliated Hospital of Kunming Medical University
Outcome results
None listed