Autism spectrum disorder
Conditions
Interventions
Short-term study: the real medicine (a kind of monosaccharide) and placebo (D-glucose) is first administered to those assigned to group A and B for one month, respectively. After a washout period of
Sponsors
Jichi Medical University
Eligibility
Sex/Gender
Male
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. More than 12 years-old male 3. 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 within three months 5. 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, irritability, dizziness, headache, edema | — |
Secondary
| Measure | Time frame |
|---|---|
| Autistic symptom (DSM-5, PARS, CARS), autistic associated symptom (ABC-J, RBS-R), circadian rhythm, endocrine and metabolic examination (oxytocin, GLP-1), brain function (eye tracker, etc), developmental or intellectual evaluation (WISC-IV, etc) | — |
Countries
Japan
Contacts
Public ContactTakahiro Ikeda
Jichi Medical University Department of Pediatrics
Outcome results
None listed