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 @ 3:29 AM
Ignite Modification Date:
2025-12-25 @ 3:29 AM
NCT ID:
NCT04401605
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent
* Male or female subjects, ≥18 years of age
* Confirmed diagnosis of UC
* Symptomatic disease defined as partial Mayo Score 2 to 7 (inclusive)
* Elevated fecal calprotectin
Exclusion Criteria:
* Women who are pregnant, nursing or expect to be pregnant
* Intolerance to fermented food
* Individuals with a body mass index (BMI) lower than 18
* Individuals diagnosed with a serious medical condition (unless approved in writing by a physician)
* Individuals who have been severely weakened by a disease or medical procedure
* Individuals with more than mild-moderate cardiovascular disease or life-threatening cancer (as determined by patient's physician) unless approved by a physician
* Individuals with history of severe cardiac disease (particularly uncompensated congestive heart failure NYHA grade 2 or more or LVEF \< 40%)
* History of relevant intestinal surgery such as total or hemi-colectomy, proctocolectomy, stoma.
Complications of disease such as extraintestinal manifestations (EIMs) are not automatically considered exclusion criteria. Appropriate medical treatment for UC and/or EIMs will not be withheld.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04401605
Study Brief:
Protocol Section:
NCT04401605