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:
2025-12-24 @ 6:34 PM
Ignite Modification Date:
2025-12-24 @ 6:34 PM
NCT ID:
NCT02361957
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed Ulcerative Colitis (left sided UC or pancolitis)
* Age 18-65 (because microbiota change at older age)
* Stable disease activity (clinical remission with CRP levels \<10mg/L and calprotectin \<100 ug/g) as measured at baseline
* Mild disease activity (P-SCCAI \<5)
* Mesalazine medication as only medication for UC with a maximum intake of 2.4 g/day
Exclusion Criteria:
* History of intestinal surgery that might interfere with the outcome of the study
* Diabetes Mellitus (medication dependent)
* Current use of antibiotics
* Current use of corticosteroids (30 days prior to the first baseline measurement).
* Treatment with other medication besides mesalazine (NSAIDs, topical or systemic steroids, immunosuppressive drugs or aspirin) one week prior the first baseline measurement.
* Use of other pre- and probiotics and not willing to stop these 2 weeks before the intervention period
* Hypersensitivity or allergy to milk protein, soy protein and gluten
* Alcohol abuse (male more than 14 servings a week, female more than 7 servings a week)
* Female patients: currently pregnant or breast-feeding or intending to become pregnant during the study
* Patients foreseen to need GI surgery during the study period
* Patients with a history of cancer
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02361957
Study Brief:
Protocol Section:
NCT02361957