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 @ 2:58 PM
Ignite Modification Date:
2025-12-24 @ 2:58 PM
NCT ID:
NCT02683759
Eligibility Criteria:
Inclusion Criteria:
* Patients who have been in symptomatic remission from Ulcerative Colitis for at least 3 months. This is defined as a Partial Mayo Index Score of 0 or 1
* Age 18 years and above
* Male or female
* Patients who are able and willing to follow the treatment given and record responses in survey form
Exclusion Criteria:
* Patients who are currently experiencing symptomatic flares of mild or moderate ulcerative colitis, or have a partial mayo index score of 2 or greater
* Patients who have been taking azathioprine or mercaptopurine for \<12 weeks for the treatment of their ulcerative colitis
* Patients who are taking steroids, immunosuppressants, or biologic agents for the treatment of their ulcerative colitis
* Patients who have severe ulcerative colitis
* Patients who are noncompliant with medication or regular follow up visits
* Patients who are unable or unwilling to record their responses in survey form
* Patients with comorbid illnesses, including: Diabetes Mellitus, Stage III or above Congestive Heart Failure, chronic pancreatitis, severe liver or renal disease
* Patients who have current gallstones or biliary dysfunction
* Patients with anemia (Hemoglobin \<10), thrombocytopenia, abnormal lymphocyte counts, or coagulation abnormalities
* Patients with current sepsis or current ongoing infection, including C. difficile colitis or enteritis
* Patients with a history of malignancy
* Patients who are currently pregnant or nursing
* Patients who are current smokers
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02683759
Study Brief:
Protocol Section:
NCT02683759