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 @ 11:20 PM
Ignite Modification Date:
2025-12-24 @ 11:20 PM
NCT ID:
NCT04335656
Eligibility Criteria:
Inclusion Criteria:
1. ≤ 100 days from T1D diagnosis based on ADA criteria
2. \> 21 days from T1D diagnosis or metabolically stable per study physician assessment
3. Males and females 3-45 years of age, inclusive, at time of screening visit
4. Peak MMTT stimulated C-peptide ≥ 0.2 nmol/L
5. Positive for at least 1 diabetes autoantibody (excluding mIAA in those who have received ≥ 2 weeks of exogenous insulin therapy) either through clinically obtained labs at time of diagnosis or as obtained at the screening visit
6. Females of child-bearing potential (defined as any female who has reached menarche (first menses), excluding those who have had a hysterectomy or are post-menopausal and must be willing to use effective birth control (which may include abstinence)) from screening visit until final study visit
7. Willing and able to give informed consent or have parent or legal guardian provide informed consent if the subject is \< 18 years of age
Exclusion Criteria:
1. Probiotic supplement use within the past month
2. Antibiotic use within the past month
3. Concurrent or recent (within the past 30 days of screening) use of non-insulin therapies aimed to control hyperglycemia
4. Females who are pregnant or lactating
5. Chronic inflammatory or autoimmune disease with exception of stable thyroid disease
6. Uncontrolled celiac disease (i.e., consuming gluten) or actively being evaluated for possible celiac disease (i.e., clinically obtained tissue transglutaminase IgA titers above reference range, being referred to gastroenterology for possible endoscopy, etc.)
7. Use of glucocorticoids or other immunosuppressive agents within 30 days of screening MMTT
8. Use of medications known to influence glucose tolerance
9. Dairy allergy
10. 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:
3 Years
Maximum Age:
45 Years
Study:
NCT04335656
Study Brief:
Protocol Section:
NCT04335656