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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02049502 |
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Date of registration:
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27/01/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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FMT in Ulcerative Colitis-Associated Pouchitis
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Scientific title:
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The Use of Fecal Microbiota Transplantation in Patients With Ulcerative Colitis-associated Pouchitis |
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Date of first enrolment:
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July 2014 |
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Target sample size:
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8 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02049502 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Virginia O. Shaffer, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Emory University |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis Associated Pouchitis
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Intervention(s)
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Procedure: sigmoidoscopy
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Biological: biologically active human fecal microbiota
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Primary Outcome(s)
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Number of Patients Who Experienced Improvement of Pouchitis Symptoms
[Time Frame: 3 months]
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Secondary Outcome(s)
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Number of Patients With Favorable Microbiota Profile
[Time Frame: 3 months]
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Secondary ID(s)
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IRB00071015
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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