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FMT Enema for Recurrent CDAD
NCT03548051Phase 2
Key facts
- Status
- Terminated
- Start
- Jan 2019
- Primary completion
- Jan 2021
- Countries
- 1
- Sponsor
- National Institute of Allergy and Infectious Diseases
- Modality
- Live Biotherapeutic Products
- Conditions
- Clostridium difficile infection (CDI)
01
Overview
Phase 2, randomised, single-blind trial in Clostridium difficile infection (CDI) comparing FMT Group with Placebo Group (2 arms). Primary endpoints: Number of Participants With a New Onset of Related Chronic Medical Condition at 1 year, Number of Participants With a Serious Adverse Event at 1 year and 3 more. Started Jan 2019; status: terminated.
02
Design
2 arms- Study design
- RandomizedSingle-blind
FMT Group
Fecal Microbiota Transplantation by enema
Placebo Group
Saline enema (with potential rescue FMT)
03
Who it enrols
Adults with recurrent CDAD (>=2 episodes) who have completed antibiotic treatment and have controlled symptoms. Excludes those with recent FMT, severe GI disorders, decompensated cirrhosis, or untreated HIV.
04
Endpoints
Primary
Number of Participants With a New Onset of Related Chronic Medical Condition
Number of Participants With a Serious Adverse Event
Number of Participants With an Adverse Event
Number of Participants With Newly Acquired Transmissible Infectious Diseases
Proportion of Participants With Clinical Response
Secondary
Number of Recurrences of Clostridium Difficile-Associated Diarrhea
Proportion of Participants With Sustained Clinical Response
Time to First Clostridium Difficile-Associated Diarrhea Reoccurrence
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