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 @ 11:30 PM
Ignite Modification Date:
2025-12-24 @ 11:30 PM
NCT ID:
NCT00568256
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of moderately severe Ulcerative Colitis
* Age 18-70
* Must have inactive disease at the time of recruitment, with at least one documented disease flare-up within the past 2 years.
* Must be on either no IBD medication or have been on a stable dose of any of the following medications for the specified amount of time: Mesalamine or Sulfasalazine for at least 6 weeks; Remicade for at least 10 weeks; Imuran or Mercaptopurine at stable and unchanged dose for at least 8 weeks.
Exclusion Criteria:
* Active Ulcerative Colitis or daily rectal bleeding for 7 days
* Taking oral steroids within 30 days of enrollment, topical agents (steroids or 5-ASA) within 14 days,immunomodulators such as Methotrexate or Imuran/6-MP and Infliximab within 90 days
* History of colon resection
* Antibiotics use within the previous 14 days
* Pregnant or lactating women
* Significant chronic disorders like severe cardiac disease (NY functional state score\>3), renal disease (creatinine\>3 mg/dL), pulmonary disease (shortness of breath at rest or need for oxygen use), active infection, or other organ system disease requiring medical visits \> 3 times /year
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00568256
Study Brief:
Protocol Section:
NCT00568256