children with autism spectrum disorder
Conditions
Sponsors
Shenzhen Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
3 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. People diagnosed with autism spectrum disorder; 2. Aged 3-12 years (3 years old and under 12 years old at the time of enrollment), no limit to gender; 3. Be Able to complete the research according to the research plan; 4. No known immune deficiency disorders; 5. The subject And/or Guardian can fully understand the content of informed consent in this study and sign the informed consent form voluntarily; 6. Those who use the following scale to score at least two items within 7 days before enrollment: (1) Autism behavior scale(ABC)>67score; (2) Autism rating scale for children(CARS)>34score; (3) Social Response Scale(SRS)>75score.
Exclusion criteria
Exclusion criteria: 1. Severe (severe and above) malnutrition was diagnosed; 2. Dependence on tube feeding (liquid food); 3. Suffering from severe gastrointestinal disease (or life-threatening) that requires immediate treatment; 4. Autoimmune diseases, including, but not limited to, rheumatoid arthritis, arthritis, systemic lupus Erythematosus, ankylosing spondylitis, Sjogren's syndrome, Hashimotos thyroiditis, toxic diffuse goiter, autoimmune hemolytic anemia, Idiopathic thrombocytopenic Purpura, Crohns disease, psoriasis, glomerulonephritis, nephrotic syndrome; 5. Has a history of severe food or drug allergies; 6. Severe fever and/or infection occurred within 7 days prior to admission; 7. Patients with renal insufficiency and liver dysfunction (ALT > 1.5ULN, AST > 1.5ULN, Cr > 1.5ULN); 8. In an immunosuppressed state (such as a neoplastic disease or organ transplant) receiving or in the process of receiving chemotherapy; 9. Inflammatory bowel disease, CELIAC disease, irritable Bowel Syndrome or Hypereosinophilic syndrome, Esophagitis, eosinophilic gastroenteritis or similar; 10. Blindness, deafness, seizures, cerebral palsy; 11. Are Participating in other clinical studies, or were enrolled within 4 weeks prior to receiving non-routine rehabilitation training as an intervention clinical study intervention; 12. Previous human immunodeficiency virus (HIV), HBV, HCV and syphilis infections, or parents with HIV; 13. Major intra-abdominal surgery (excluding appendectomy or cholecystectomy) and/or invasive operationhospitalization planned during the study period were performed within the last 60 days prior to screening; 14. Any clinically significant condition or condition that the lead researcher believes would endanger the safety or rights of the subject or confound the results of the study, or that the researcher considers unsuitable for participation in this study 3.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Autism rating scale for children;Social Response Scale;Autism behavior scale; | — |
Countries
China
Contacts
Public ContactChen Ye
Shenzhen Hospital of Southern Medical University
Outcome results
None listed