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 @ 7:03 PM
Ignite Modification Date:
2025-12-24 @ 7:03 PM
NCT ID:
NCT01026857
Eligibility Criteria:
Inclusion Criteria:
* Have read the Information for the Patient and signed the Informed Consent Form.
* Age comprised between 18 and 75 included.
* If female, not pregnant or nursing.
* For women of childbearing potential, willingness to avoid a pregnancy during the treatment period and for at least 1 month from the last dose of drug.
* Availability of a pancolonoscopy and histology both confirming the diagnosis of active ulcerative colitis.
* Disease Activity Index comprised between 3 and 10, inclusive, (mild to moderate ulcerative colitis).
* On one of the following treatments for ulcerative colitis prior to baseline visit:
1. Stable background oral aminosalicylates (mesalazine, balsalazide, olsalazine) or sulfasalazine therapy for greater than or equal to 4 weeks prior to baseline assessments.
2. Stable background mercaptopurine or azathioprine for greater than or equal to 12 weeks prior to baseline assessments.
Exclusion Criteria:
* First diagnosis of ulcerative colitis.
* Crohn's disease.
* Current or previous (in the last 10 days preceding the screening) use of systemic corticosteroids.
* Use of antibiotics in the last 10 days preceding the screening.
* Use of NSAID's in the last 10 days preceding the screening.
* Use of probiotics in the last 10 days preceding the screening
* Positive stool culture (when performed, according to Investigator's judgment, to assess possible parasitologic infection(s)).
* Significantly impaired liver, renal, pulmonary or cardiovascular function.
* History of colon resection.
* Diverticulitis.
* Diagnosis of proctitis
* Stable rectally administered therapy in the last 10 days.
* Active or chronic infection(s).
* Simultaneous participation in another clinical trial, or participation in any clinical trial involving investigational drugs within 3 months from enrolment into the present study.
* Any physical or psychological condition in a patient that could let the investigator suspect his/her poor compliance.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01026857
Study Brief:
Protocol Section:
NCT01026857