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 @ 5:53 PM
Ignite Modification Date:
2025-12-24 @ 5:53 PM
NCT ID:
NCT02168868
Eligibility Criteria:
Inclusion Criteria:
1. Male and female children
2. Child aged 2-12 years with diagnosed ASD according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV (299.00) or DSM-V (299.00) OR Child aged 2-18 years diagnosed ASD according to DSM-IV (299.00) or DSM-V (299.00) AND scheduled to undergo stem cell transplantation OR Child aged 10-19 months not diagnosed with ASD but with a sibling diagnosed with ASD according to (DSM)-IV (299.00) or DSM-V (299.00) (herein termed "high-risk infants") OR Mothers of recruited high-risk infants OR A typically developing child aged 2-12 years with no signs of ASD or history of ASD in the immediate family
3. Informed consent signed by the parent/legal guardian
Exclusion Criteria:
1. Child and/or mother completed treatment with systemic steroids or immune suppressants less than 4 weeks before the screening visit
2. Child and/or mother diagnosed with severe infectious diseases or sepsis over the last 6 months
3. Child with ASD treated for a severe convulsive disorder (intractable seizures)
4. Child and/or mother with hematological or malignant disorder
5. For children in the SCT cohort: No new planned immune-modulating treatment (other than SCT) for at least 6 months before or after planned stem cell transplantation date
6. If the PI suspects that the participant will not comply with study requirements, the participant may be excluded.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
10 Months
Maximum Age:
19 Years
Study:
NCT02168868
Study Brief:
Protocol Section:
NCT02168868