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 @ 1:05 PM
Ignite Modification Date:
2025-12-24 @ 1:05 PM
NCT ID:
NCT02428361
Eligibility Criteria:
Inclusion Criteria:
Both acute and chronic pouchitis will be eligible for treatment with FMT. Patients eligible for FMT will include:
1. Patients with history of proctocolectomy with IPAA with pouchitis confirmed by endoscopy and pathology.
2. Concurrent therapies with mesalamine, immunomodulators, corticosteroids and biologic agents will be allowed to continue during study.
Exclusion Criteria:
1. Female patients who are pregnant.
2. Patients with severe immunosuppression (absolute neutrophil count \< 1000 or CD4 count \<200).
3. Patients with diagnosis of ileal Crohn's Disease.
4. Patients with untreated enteric infection.
5. Patients with fistulizing disease.
6. Patients with gastroparesis or dysphagia will not be eligible for the arm of the study allowing for administration of weekly capsules
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02428361
Study Brief:
Protocol Section:
NCT02428361