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:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT04552002
Eligibility Criteria:
Inclusion Criteria:
* Patients diagnosed with type 1 diabetes
* Patients on insulin therapy
* Patients on antibiotics
* Pregnant and lactating women
* Smoking individuals
* Patients with comorbidities (except for hyperlipidemia and blood pressure)
* Patients taking immunosuppressants
* Patients taking probiotics, prebiotics or synbiotics
Exclusion Criteria:
* Patients with prediabetes (HbA1c of 5.7- 6.4% or a fasting plasma glucose of 100 -125 mg/dl)
* Patients with type 2 diabetes (HbA1c of ≥ 6.5% or a fasting plasma glucose of ≥ 126 mg/dl
* Male and female patients aged (18-70) years
* Patients with HbA1c of ≥ 5.7 or a fasting plasma glucose of ≥100 mg/dl
* BMI ≥ 25
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04552002
Study Brief:
Protocol Section:
NCT04552002