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 @ 12:57 PM
Ignite Modification Date:
2025-12-24 @ 12:57 PM
NCT ID:
NCT04141761
Eligibility Criteria:
Inclusion Criteria:
* Patients must meet all of the following criteria:
1. Males and females 5-17 years of age with a clinical diagnosis of T1D within the past 90 days
2. Positive for ≥ 1 diabetes-related autoantibodies (IAA, GAD, IA-2, or ZnT8)
3. Stimulated C-peptide area under the curve (AUC) of ≥ 0.2 nmol/L during a mixed meal tolerance test
4. Treatment naïve of any immunomodulatory agent
Exclusion Criteria:
* Patients must NOT meet any of the following criteria:
1. Probiotic use within 1 month of screening visit
2. Presence of severe, active disease that requires the use of chronic medication, with the exception of well-controlled autoimmune thyroiditis/hypothyroidism
3. Diabetes other than T1D
4. Female participants of child-bearing age with reproductive potential must not be knowingly pregnant
5. Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
17 Years
Study:
NCT04141761
Study Brief:
Protocol Section:
NCT04141761