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 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT04073927
Eligibility Criteria:
Inclusion Criteria:
1. Male or female patients ≥ 18 years of age with a diagnosis of type 1 diabetes (age at onset \<40 years; permanent insulin treatment initiated within 1 year of diagnosis)
2. Albuminuria: UACR \> 30 mg/g documented in medical history
3. Calprotectin quick-test result ≥ 50 μg/g (CalDetect 50/200, Preventis) between visit 1 and visit 2.
4. Able to understand the written patient information and give informed consent
Exclusion Criteria:
1. Known inflammatory bowel disease
2. IBD symptoms due to investigators opinion
3. Known celiac disease
4. Existing ostomy
5. Known rheumatic disorders treated with anti-inflammatory agents
6. Known hyperthyroidism or hypothyroidism Butyful Protocol - page 12 - Version 3, 25.02.2019
7. Active immunosuppressant therapy with systemic effect due to investigator's opinion
8. Current cancer treatment or within five years from baseline (except basal cell skin cancer or squamous cell skin cancer)
9. eGFR\<15, dialysis or kidney transplantation
10. Diagnosis of non-diabetic CKD
11. Active antibiotic therapy until 30 days ahead of screening
12. Unable to participate in study procedures
13. Not able to assess calprotectin by quick test in two attempts
14. Any clinically significant disorder, except for conditions associated with type 1 DM history, which in the Investigators opinion could interfere with the results of the trial
15. Pregnancy or lactation
16. Participation in another intervention study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04073927
Study Brief:
Protocol Section:
NCT04073927