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 @ 5:43 PM
Ignite Modification Date:
2025-12-24 @ 5:43 PM
NCT ID:
NCT03364868
Eligibility Criteria:
Inclusion Criteria:
1\. Infant between the ages of 4 months and 7 months at the time of randomization.
2\. A high genetic risk (\>10%) to develop beta-cell autoantibodies by age 6 years:
1. For infants without a first degree family history of type 1 diabetes, high genetic risk is defined as a DR3/DR4-DQ8 or DR4-DQ8/DR4-DQ8 genotype, and a genetic risk score that is \>14.4.
2. For infants with a first degree family history of type 1 diabetes, high genetic risk is defined as having HLA DR4 and DQ8, and none of the following protective alleles: DRB1\*1501, DQB1\*0503.
3. Solid foods introduced into diet of infant
4. Written informed consent signed by the custodial parent(s).
Exclusion Criteria:
1. Concomitant disease or treatment that may interfere with the assessments, as judged by the investigators.
2. Any condition that could be associated with poor compliance.
3. Any medical condition or medical condition coexisting, which, in the opinion of the investigator, may jeopardize the participant's safe participation in the study.
4. Diagnosis of diabetes at the time of recruitment.
5. Participation in another clinical trial.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
4 Months
Maximum Age:
7 Months
Study:
NCT03364868
Study Brief:
Protocol Section:
NCT03364868