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 @ 7:08 PM
Ignite Modification Date:
2025-12-24 @ 7:08 PM
NCT ID:
NCT07032857
Eligibility Criteria:
* Children with a clinical diagnosis of ASD according to DSM-IV, confirmed by ADOS-G.
* Consumption of a gluten-containing diet.
* Negative celiac disease serology (EMA and anti-TG2 IgA antibodies).
* Absence of IgE- or non-IgE-mediated food allergies.
Exclusion Criteria:
* Known neurological disorders.
* Major congenital anomalies.
* Severe head trauma.
* Chronic gastrointestinal diseases.
* Special diets (e.g., gluten-free or gluten/casein-free).
* Antibiotic or probiotic/prebiotic intake in the previous 4 weeks.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
14 Years
Study:
NCT07032857
Study Brief:
Protocol Section:
NCT07032857