Autism Spectrum Disorder
Conditions
Interventions
treatment group:Recombinant human interleukin-2 (IL-2) for injection is reconstituted with 2.0 mL of sterile water for injection and administered by subcutaneous injection.
The dosage is 16,000 IU/kg
Sponsors
The Second Affiliated Hospital of Kunming Medical University
Eligibility
Sex/Gender
All
Age
3 Years to 16 Years
Inclusion criteria
Inclusion criteria: All participants must meet all of the following inclusion criteria: 1. Age (1) Aged 3–16 years. 2. Abnormal immune laboratory findings (meeting any one of the following criteria) (1) Regulatory T (Treg) cells = 2.44%; (4) Th2 lymphocyte subset >= 0.73%; (5) Th17 lymphocyte subset >= 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 >= 2.81 pg/mL; (12) Peripheral blood cytokine IL-17A >= 3.05 pg/mL. 3. Diagnostic criteria (1) Diagnosis of autism spectrum disorder (ASD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by the Autism Diagnostic Observation Schedule (ADOS) and/or the Autism Diagnostic Interview–Revised (ADI-R).
Exclusion criteria
Exclusion criteria: Exclude any of the following criteria: 1. A medical history of other neurological/psychiatric complications, such as seizures, schizophrenia or substance abuse; 2. Those patients who received relevant treatment ; 3. Those patients who have taken in prescribed antibiotics, yogurt or probiotic products or immunomodulatory drugs within two weeks; 4. Allergic or allergic constitution to IL-2 or similar products; 5. Patients with abnormal liver and kidney functions or patients with liver and kidney diseases; 6. Patients with blood system diseases; 7. Patients with organic diseases; 8. Other situations that researchers considered it inappropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sociological behavior score;Immunological index detection: such as number of regulatory T cells, TFH cell and other immunological indexes; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse reaction rate: such as injection reaction, vomiting, headache, etc; | — |
Countries
China
Contacts
Public ContactLin Zhao, Xia Cao
The Second Affiliated Hospital of Kunming Medical University
Outcome results
None listed