Status:
TERMINATED
FMT Versus Antimicrobials for Initial Treatment of Recurrent CDI
Lead Sponsor:
Endeavor Health
Conditions:
Clostridium Difficile Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of the study is to determine the safety and efficacy of Fecal Microbiota Transplant (FMT) for the treatment of the recurrence of Clostridium difficile infection (CDI) as compared to standa...
Detailed Description
This trial is an open-label, randomized, controlled trial evaluating the safety and efficacy of fecal microbiota transplantation (FMT) for the treatment of the recurrence of Clostridium difficile infe...
Eligibility Criteria
Inclusion
- Diagnosis of active C. difficile infection, defined as \> 3 diarrheal stools per day and a positive C. difficile PCR assay
- Hospitalized patient presenting with first relapse of CDI occuring between 15 and 90 days after an index episode of CDI
Exclusion
- Pregnancy
- Neutropenia (absolute neutrophil count \<1000/microliters)
- Contraindication for retention enema
- Food allergy not controlled in the donor diet
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2020
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT02255305
Start Date
January 1 2015
End Date
January 1 2020
Last Update
March 3 2023
Active Locations (1)
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1
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201