Autism
Conditions
Interventions
Experimental group:Oral therapeutic beverage
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
3 Years to 9 Years
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with autism meet the diagnostic criteria set by child psychiatrists according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) published by the American Psychiatric Association. 2. Age between 3 to 9 years old (i.e., at least 3 years old but less than 10 years old at the time of screening), with no gender restrictions. 3. Capable of completing the study according to the trial protocol requirements. 4. No known immune deficiency diseases. 5. The legal guardian can fully understand the content of this study's informed consent and voluntarily sign the Informed Consent Form (ICF). 6. At the time of screening, the ABC score is >62 points and the CARS score is > 30.
Exclusion criteria
Exclusion criteria: 1.Diagnosed with severe (moderate or severe) malnutrition; 2.Dependent on tube feeding (liquid food); 3.Suffering from serious gastrointestinal diseases that require immediate treatment (or life-threatening); 4.Diagnosed with intestinal obstruction (including partial obstruction), or with severe ulcerative intestinal damage; 5.Diagnosed with immunodeficiency diseases, autoimmune diseases, including but not limited to: rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis, Sjögren's syndrome, Hashimoto's thyroiditis, toxic diffuse goiter, autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura, Crohn's disease, psoriasis, glomerulonephritis, nephrotic syndrome; 6.History of severe food or drug allergies; 7.Severe fever and/or serious infection within 7 days before enrollment; 8.Patients with renal insufficiency and liver dysfunction: Alanine aminotransferase (ALT) > 1.5 times the Upper Limit of Normal (ULN); Or Aspartate aminotransferase (AST) > 1.5 times ULN; Or serum creatinine > 1.5 times ULN; 9.In an immunosuppressed state (such as neoplastic diseases or organ transplantation) and have received or are receiving chemotherapy; 10.Suffering from inflammatory bowel disease, celiac disease, irritable bowel syndrome, or eosinophilia, esophagitis, eosinophilic gastroenteritis, or similar conditions; 11.Suffering from diseases such as blindness, deafness, cerebral palsy; 12.Participating in other clinical studies, or received interventional clinical study interventions with unconventional rehabilitation training within 4 weeks before enrollment; 13.History of HIV infection, or HBV infection, or HCV infection, or syphilis infection, or parents with HIV infection; 14.Major intra-abdominal surgery within the last 60 days before screening (appendectomy or cholecystectomy excluded) and/or planned invasive surgery/hospitalization during the study period; 15.The principal investigator believes the subject has certain prominent symptoms (including but not limited to stereotypy, aggression, self-harm, destruction, severe emotional and behavioral problems, and extreme hyperactivity, etc.), requiring pharmacological treatment; 16.Any clinically significant condition that the principal investigator believes would endanger the safety or rights of the subject or confound the study results, or the investigator deems unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Childhood Autism Rating Scale (CARS) score;Intestinal flora;Adverse Events; | — |
Countries
China
Contacts
Public ContactZhang Jinping
Shanghai Sixth People's Hospital
Outcome results
None listed