Safety and efficacy of rare sugar in children with autism spectrum disorder

Not Applicable

Recruiting

• Conditions: Autism spectrum disorder

• Registration Number: JPRN-UMIN000035175
• Lead Sponsor: Jichi Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

Not provided

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

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, irritability, dizziness, headache, edema

Secondary Outcome Measures

Name	Time	Method
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)