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 @ 10:40 PM
Ignite Modification Date:
2025-12-24 @ 10:40 PM
NCT ID:
NCT03337035
Eligibility Criteria:
Inclusion Criteria:
1. Age between 3-25years old;
2. Pre-existing diagnosis of autism; subjects may be asked to provide documentation confirming diagnosis by DSM-V-TR criteria, ADOS, ADI-R, or other clinical forms
3. A care provider who can reliably bring the participant to study visits;
4. No planned changes in medications or psychosocial interventions during trial (stable medications within the last 2 weeks);
5. Willingness to provide blood samples
Exclusion Criteria:
1. Pregnant woman (before or during the study).
2. Comorbidity of other neurological and/or psychiatric disorders such as unstable seizures, schizophrenia, schizoaffective disorder, bipolar disorders or history of substance abuse.
3. Psychotropic medication use
4. Subjects with active cardiovascular disease that is not controlled by medication.
5. Oxytocin, antibiotic, or probiotic use within the last 30 days.
6. Regular nasal obstruction or nosebleeds
7. Significant hearing, vision, or motor impairments
8. Habitual consumption of large volumes of water
9. Started taking new medications within the last 2 weeks
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
25 Years
Study:
NCT03337035
Study Brief:
Protocol Section:
NCT03337035