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:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT02677051
Eligibility Criteria:
Inclusion Criteria:
* Autistic disorder diagnosis.
* Age between 13-30 years.
* Male gender.
Exclusion Criteria:
* Absence of a parent or legal guardian and consent,
* Those that can not or will not complete 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 (\> 2x upper limit of normal).
* Impaired thyroid function (TSH outside normal limits).
* Current infection or treatment with antibiotics.
* Chronic medical disorder (e.g., cardiovascular disease, stroke or diabetes) or major surgery within 3 months prior to enrollment.
* Less than 13 years or more than 30 years of age.
* Female gender.
* A diagnosis of autism spectrum disorder other than autistic disorder, for example, Asperger, Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) etc.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
13 Years
Maximum Age:
30 Years
Study:
NCT02677051
Study Brief:
Protocol Section:
NCT02677051