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 @ 2:19 AM
Ignite Modification Date:
2025-12-25 @ 2:19 AM
NCT ID:
NCT02142634
Eligibility Criteria:
Inclusion Criteria:
* Histologically established diagnosis of incomplete microscopic colitis (MCi)
* History of chronic non-bloody, watery diarrhoea
* Clinically active disease
Exclusion Criteria:
* Other significant abnormalities in colonoscopy
* Infectious cause of diarrhoea
* Clinical suspicion of drug-induced diarrhoea
* Prior and present MC
* History of bowel resection
* Radiation therapy of the abdominal or pelvic region
* Positive antibody titres for celiac disease
* Untreated active thyroid dysfunction
* Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder reducing life expectancy
* Abnormal hepatic function
* Tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer disease, glaucoma, cataract, or infection if careful medical monitoring is not ensured
* History of colorectal cancer
* History of cancer (other than colorectal) in the last 5 years
* Therapy with immunomodulators/budesonide or other steroids/antibiotics/anti-diarrhoeal drugs
* Current or intended pregnancy or breast-feeding
* Doubt about the patient's cooperation, e.g. because of addiction to alcohol or drugs
* Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02142634
Study Brief:
Protocol Section:
NCT02142634