Impairments in social and language skills.Obesty
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. The diagnosis for ASD was made based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) 2. Parents or legal guardians of the participant provide written informed consent for participation.
Exclusion criteria
Exclusion criteria: 1. Comorbid severe neurodegenerative, metabolic, and progressive disorder 2. Severe abnormalities of blood or electrocardiogram examination 3. Persistent diarrhea 4. Severe drug or food allergy 5. Those who changed one's medicine related to symptoms of ASD, treatment of liver dysfunction or cholesterolemia within three months 6. Responsible doctors judged a patient inappropriate for the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event: condition or frequency of stool, blood examination, weight loss, hypertension, fatigue, anxiety, dizziness, headache, edema. | — |
Secondary
| Measure | Time frame |
|---|---|
| Autistic symptom (DSM-5, PARS, CARS2, Sensory Profile, SCQ, SRS2), autistic associated symptom (ABC-J, RBS-R, Vineland2), circadian rhythm, endocrine and metabolic examination (oxytocin, GLP-1), brain function (eye tracker, etc), developmental or intellectual evaluation (WISC-IV, etc) | — |
Contacts
Jichi Medical University Hospital