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 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 12:27 AM
NCT ID:
NCT02093767
Eligibility Criteria:
Inclusion Criteria:
* Males and females 18 - 65 years of age.
* Diagnosis of ulcerative colitis established by previous endoscopies, with histology and clinical course consistent with diagnosis.
* Colitis must extend for more than 15 cm above the anal verge, and involve at least the rectosigmoid.
* Mild to moderately active ulcerative colitis defined by a minimum score of 3 and a maximum score of 8 on the 12 point Mayo scale. Mayo scores are assigned by (1) stool frequency, (2) rectal bleeding, (3) endoscopic findings and (4) physician's overall assessment of disease severity
* At least one previous episode of ulcerative colitis, prior to the current episode
* Duration of current symptomatic episode less than 4 weeks.
* Ability to give valid informed consent.
* For females of childbearing potential, a negative pregnancy test.
Exclusion Criteria:
* Crohn's disease or pouchitis.
* Current infectious enteritis.
* Use of oral steroids within the last 4 weeks of the screening visit.
* Use of antibiotics within the last 2 weeks of the screening visit
* Change in dose of oral 5-ASA products within the last 2 weeks of the screening visit.
* Topical 5-ASA or steroids within 7 days prior to the baseline endoscopy
* Use of immunosuppressive or biological agent within 3 months of screening.
* Use of NSAIDS one week before screening.
* Use of anti-diarrheal drugs within the last 1 week of the screening visit.
* Use of probiotic preparations either prescribed or over-the-counter within two weeks of screening.
* Use of natural health products within 2 weeks of screening (except multivitamins and minerals)
* Significant hepatic, renal, endocrine, respiratory, neurological or cardiovascular disease as determined by the investigator
* Imminent need for colectomy
* Presence of severe UC (defined as a Mayo of 9 or greater)
* Pregnancy or lactation
* Inability to give a valid informed consent or to properly comply with study procedures for any reason.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02093767
Study Brief:
Protocol Section:
NCT02093767