Recruitment

Recruitment Status
Completed
Estimated Enrollment
10

Inclusion Criteria

male or female
age 18 to 65 years
patients of Emory Clinic and/or Emory University Hospital
...
male or female
age 18 to 65 years
patients of Emory Clinic and/or Emory University Hospital
ulcerative colitis-associated pouchitis

Exclusion Criteria

Exposure to immunosuppressive therapy (defined as steroid, etanercept, or anti-tumor necrosis factor (TNF)agents) within 1 month prior to enrollment
Age <18 years or >65 years of age
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
Age <18 years or >65 years of age
Administration of investigational drug within one month prior to planned FMT
Absolute neutrophil count (ANC) less than 1000 or history of opportunistic infection
Pregnant or breastfeeding women
Documented active infection of any kind
Suspected Crohn's disease
Concomitant Clostridium difficile 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

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

male or female
age 18 to 65 years
patients of Emory Clinic and/or Emory University Hospital
...
male or female
age 18 to 65 years
patients of Emory Clinic and/or Emory University Hospital
ulcerative colitis-associated pouchitis

Exclusion Criteria

Exposure to immunosuppressive therapy (defined as steroid, etanercept, or anti-tumor necrosis factor (TNF)agents) within 1 month prior to enrollment
Age <18 years or >65 years of age
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
Age <18 years or >65 years of age
Administration of investigational drug within one month prior to planned FMT
Absolute neutrophil count (ANC) less than 1000 or history of opportunistic infection
Pregnant or breastfeeding women
Documented active infection of any kind
Suspected Crohn's disease
Concomitant Clostridium difficile 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

Locations

Atlanta, Georgia, 30342
Atlanta, Georgia, 30322
Atlanta, Georgia, 30342
Atlanta, Georgia, 30322

Tracking Information

NCT #
NCT02049502
Collaborators
Not Provided
Investigators
  • Principal Investigator: Virginia O. Shaffer, MD Emory University
  • Virginia O. Shaffer, MD Emory University