Rare sugar in the patient with autism
Phase 1
Recruiting
- Conditions
- Impairments in social and language skills.Obesty
- Registration Number
- JPRN-jRCTs031180411
- Lead Sponsor
- Monden Yukifumi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 30
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse event: condition or frequency of stool, blood examination, weight loss, hypertension, fatigue, anxiety, dizziness, headache, edema.
- Secondary Outcome Measures
Name Time Method 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)