FMT in Ulcerative Colitis-Associated Pouchitis
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 10
Inclusion Criteria
- ulcerative colitis-associated pouchitis
- male or female
- age 18 to 65 years
- ...
- ulcerative colitis-associated pouchitis
- male or female
- age 18 to 65 years
- patients of Emory Clinic and/or Emory University Hospital
Exclusion Criteria
- Age <18 years or >65 years of age
- Pregnant or breastfeeding women
- Absolute neutrophil count (ANC) less than 1000 or history of opportunistic infection
- ...
- Age <18 years or >65 years of age
- Pregnant or breastfeeding women
- Absolute neutrophil count (ANC) less than 1000 or history of opportunistic infection
- 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
- Concomitant Clostridium difficile infection
- Administration of investigational drug within one month prior to planned FMT
- Exposure to immunosuppressive therapy (defined as steroid, etanercept, or anti-tumor necrosis factor (TNF)agents) within 1 month prior to enrollment
- Documented active infection of any kind
- Suspected Crohn's disease
Summary
- Conditions
- Ulcerative Colitis Associated Pouchitis
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
Inclusion Criteria
- ulcerative colitis-associated pouchitis
- male or female
- age 18 to 65 years
- ...
- ulcerative colitis-associated pouchitis
- male or female
- age 18 to 65 years
- patients of Emory Clinic and/or Emory University Hospital
Exclusion Criteria
- Age <18 years or >65 years of age
- Pregnant or breastfeeding women
- Absolute neutrophil count (ANC) less than 1000 or history of opportunistic infection
- ...
- Age <18 years or >65 years of age
- Pregnant or breastfeeding women
- Absolute neutrophil count (ANC) less than 1000 or history of opportunistic infection
- 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
- Concomitant Clostridium difficile infection
- Administration of investigational drug within one month prior to planned FMT
- Exposure to immunosuppressive therapy (defined as steroid, etanercept, or anti-tumor necrosis factor (TNF)agents) within 1 month prior to enrollment
- Documented active infection of any kind
- Suspected Crohn's disease
Tracking Information
- NCT #
- NCT02049502
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Virginia O. Shaffer, MD Emory University
- Virginia O. Shaffer, MD Emory University