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 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 1:41 AM
NCT ID:
NCT04133194
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent
* Age between and including 18 and 60
* Diagnosed with UC according to the Copenhagen Diagnostic Criteria
* Length of disease of max. 10 years
* Stable remission on 5-ASA (defined as partial Mayo score ≤1) for at least 2 months without need for oral corticosteroids before inclusion.
* Endoscopic remission defined as Mayo Clinic Endoscopic Score \< 2
* Have had a relapse within the last 2 years
* Defined as the need of escalation of treatment or change medical treatment.
Exclusion Criteria:
* Evidence of infectious diarrhoea (i.e. pathogenic viruses, bacteria or Clostridium difficile toxin in stool culture) within the last month
* On immunomodulators, including methotrexate
* On any biological therapy
* Any previous abdominal surgery related to UC
* Any chronic infections (e.g. HBV, HCV, HIV)
* Any severe concomitant cardiovascular, autoimmune, hematologic, hepatic, renal, endocrine, oncologic or psychiatric disorder, which in the opinion of the investigator might have an influence on the patient's compliance or the interpretation of the results
* Well-founded doubt about the patient's cooperation, e.g., because of addiction to alcohol or drugs in the opinion of the investigators.
* Participation in another clinical trial within the last 30 days, or simultaneous participation in another clinical trial.
* Any previous documented allergic reaction to tested the medical drugs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT04133194
Study Brief:
Protocol Section:
NCT04133194