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 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT02683733
Eligibility Criteria:
Inclusion Criteria:
* Patients who have mild to moderate ulcerative colitis, with a current Partial Mayo Index greater than or equal to 2 and less than or equal to 6
* Age 18 years and above
* Male or female
* Patients who have given consent and area able to follow the treatment given
* Patients who are able to record their responses in survey form at regular follow-up visits
Exclusion Criteria:
* Patients who are in remission from ulcerative colitis, or who have a Partial Mayo Index Score of 0 or 1
* Patients who have been taking azathioprine or mercaptopurine for \<12 weeks for the treatment of their ulcerative colitis
* Patients who are taking steroids or biologic agents for the treatment of their ulcerative colitis
* Patients who have severe ulcerative colitis, or who have a Partial Mayo Index Score of 7 or above
* Patients who are noncompliant with medication or regular follow up visits
* Patients who are unable to 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 any biliary dysfunction
* Patients with anemia (Hemoglobin \<10), thrombocytopenia, abnormal lymphocyte counts, or coagulation abnormalities
* Patients who currently have an ongoing severe infection/sepsis
* 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:
NCT02683733
Study Brief:
Protocol Section:
NCT02683733