Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2025-12-25 @ 12:58 AM
NCT ID:
NCT01474993
Eligibility Criteria:
Inclusion Criteria:
* Autism diagnosis. Quantitative autism traits and severity for diagnosis of autism will be assessed using the ADOS-G (Modules 1-4 and Severity), Social Responsiveness Scale (SRS; child and adult forms), Clinical Global Impression-Severity (CGI-S) and Aberrant Behavior Checklist-Withdrawal subscale (ABC-W).
Exclusion Criteria:
* Absence of a parent or legal guardian and consent
* Unavailability for all visits and adherence to study regimen
* Seizure within 2 years of screening
* Impaired renal function (serum creatinine \> 1.2 mg/dl), impaired hepatic function (AST/ALT \> 2x upper limit of normal), impaired thyroid function (TSH outside normal limits)
* Current infection or treatment with antibiotics; AND
* Chronic medical disorder (e.g., cardiovascular disease, stroke or diabetes) or major surgery within 3 months prior to enrollment.
* A diagnosis of autism spectrum disorder other than autism, for example, Asperger's, PDD-NOS etc.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
13 Years
Maximum Age:
30 Years
Study:
NCT01474993
Study Brief:
Protocol Section:
NCT01474993