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 @ 3:08 AM
Ignite Modification Date:
2025-12-25 @ 3:08 AM
NCT ID:
NCT00751933
Eligibility Criteria:
Inclusion Criteria:
* ulcerative colitis of at least 4 months duration
* disease activity index score (Walmsley) \>5 and \</=13
* patients taking no ulcerative colitis relevant medicine, or stable doses of aminosalicylates or maximum 10mg prednisolon daily the last 2 weeks before study entry. They must remain on the same dose throughout the study (6 months).
* stool examination negative for enteric pathogens, clostridium difficile toxin and parasites
Exclusion Criteria:
* ulcerative colitis disease activity index \>13
* symptoms of bowel obstruction
* other serious medical condition
* use of any of the study vaccines during the last two years
* use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first vaccine dose, or planned use during study period
* pregnant or planning to become pregnant
* breastfeeding
* chronic administration of prednisolone more than 10mg per day or steroids of equivalent dose the last 2 weeks before the first vaccine dose
* treatment with anti-tumor necrosis factor within 3 months prior to the first vaccine dose
* use of other immunosuppressants or immune modifying drugs within 30 days prior to the first vaccine dose
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00751933
Study Brief:
Protocol Section:
NCT00751933