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:
2025-12-26 @ 4:03 PM
Ignite Modification Date:
2025-12-26 @ 4:03 PM
NCT ID:
NCT04121806
Eligibility Criteria:
Inclusion Criteria:
* • Females and Males between the ages of 18 - 75 years of age at the time of enrolment
* Must have established diagnosis of UC by standard endoscopic, radiographic, or histological criteria
* Must have active UC defined by having a Mayo score equal to or greater than 2 within two months prior to enrollment
* Must have had \> 10cm involvement at some point in their disease history
* FCP\>250 or active endo within 6 months
* If a smoker, must not change smoking habits (frequency) during the course of the study
* If receiving medical therapy, no baseline therapy change within 4 weeks of study initiation and no change during the course of the study
Exclusion Criteria:
* • Uncontrolled inflammation which will likely require surgery or escalation of therapy within 4 weeks of enrollment
* Pregnant or lactating females
* Allergy or intolerance to key or a great number food components of the study diet
* Current NSAID use
* Diagnosed with PSC
* Using topical therapies or suppositories
* Antibiotic use within 4 weeks of the study enrollment or during the study
* Confirmed C. difficile infection within 3 months of recruitment;
* Diagnosis of primary PSC;
* Currently using topical therapies or suppositories
* History of dysplasia or colorectal neoplasia.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04121806
Study Brief:
Protocol Section:
NCT04121806