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 @ 3:54 AM
Ignite Modification Date:
2025-12-25 @ 3:54 AM
NCT ID:
NCT02049502
Eligibility Criteria:
Inclusion Criteria:
* male or female
* age 18 to 65 years
* ulcerative colitis-associated pouchitis
* patients of Emory Clinic and/or Emory University Hospital
Exclusion Criteria:
* Age \<18 years or \>65 years of age
* Exposure to immunosuppressive therapy (defined as steroid, etanercept, or anti-tumor necrosis factor (TNF)agents) within 1 month prior to enrollment
* Concomitant Clostridium difficile infection
* Suspected Crohn's disease
* Documented active infection of any kind
* Patients on anti-coagulant therapy, with platelet count less than 50,000, significant anemia with hemoglobin less than 7 or those with other conditions that place them at increased risk of bleeding
* Absolute neutrophil count (ANC) less than 1000 or history of opportunistic infection
* Administration of investigational drug within one month prior to planned FMT
* Pregnant or breastfeeding women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02049502
Study Brief:
Protocol Section:
NCT02049502