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 @ 12:20 PM
Ignite Modification Date:
2025-12-24 @ 12:20 PM
NCT ID:
NCT05521061
Eligibility Criteria:
Inclusion Criteria:
* Being at least 48 months of age
* Diagnosis period \<100 days, in the early stage
* Exogenous insulin requirement \> 0.5 U/kg/day in the late-stage
* Positive at least one autoantibody associated with type 1 DM (ICA, IAA, GADA)
* C-peptide level \<0.2 nmol/L during MMTT
* Between the 3rd percentile and the 97th percentile weight for age (between -2SD and +2SD)
Exclusion Criteria:
* Being breastfed despite the age of 48 months
* Failure to meet the diagnostic criteria for autoimmune type 1 DM (autoantibody negative)
* Co-morbidity illness
* To have taken antibiotics, probiotics, prebiotics and inflammatory drugs in the last one month before participating in the study or during the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
16 Years
Study:
NCT05521061
Study Brief:
Protocol Section:
NCT05521061