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NCT02465463 · ClinicalTrials.gov registry record · Phase 1
Early FMT for C.Difficile
A Phase 1 study of Clostridium Difficile, sponsored by Emory University.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
- 1
- Study location
NCT02465463 is a Phase 1 study of Clostridium Difficile that has completed, run by Emory University. The registered enrollment target is 13 participants, below the 459-participant average among 6 other Clostridium Difficile trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02465463, a Phase 1 study of Clostridium Difficile, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
- 1
- Study location
Study Summary
Clostridium difficile infection (CDI) has increased worldwide in both frequency and severity. It is the leading cause of hospital acquired infection in developed countries and has been associated with at least 14,000 deaths per year in the United States. With 3 million cases/ year, the annual cost for treating the infection is exceeding 3 billion dollars. It can also have a profound negative impact on quality of life. The investigators believe that patients who are at high risk of relapse after a first CDI episode would benefit from early fecal microbial transplant (FMT). The proposed study will produce preliminary data regarding safety and efficacy and potential for cost effectiveness for the use of early fecal transplant in those patients with their first episode of non-refractory CDI who are predicted to have a high rate of recurrence based on previously published risk factors. The investigators will be better prepared to test the efficacy of this approach in a future multicenter clinical trial in a randomized controlled fashion. The purpose of this study is to compare the effectiveness and safety of early fecal transplant using donor stool from a healthy person in a group of patients who are diagnosed with their first episode of Clostridium difficile infection and are predicted to have a high chance of the infection returning against a similar group of patients who receive current standard of care for treatment of C.difficile. The investigators hypothesize: * that clinical remission rates at 12 weeks as noted by absence of clinical symptoms and/or negative C.difficile stool polymerase chain reaction (PCR) will be greater in the experimental arm compared to the control arm * that patients in the experimental group will have a low microbial diversity prior to FMT but will exhibit a high microbial diversity after the FMT that resembles the respective donor * that the microbial diversity will be diminished in both groups at the time of enrollment, but the experi
Conditions Studied
Interventions
- PROCEDURE Fecal microbiota transplant (FMT)
- DEVICE flexible sigmoidoscopy
Study Locations (1)
Georgia
- Emory University - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2015-06 |
| Est. Completion | 2016-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02465463
The ClinicalTrials.gov registry entry for NCT02465463 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 459-participant average among 6 other Clostridium Difficile trials with a reported enrollment target (97% lower). The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Clostridium Difficile appearing as the primary indexed condition, and to 2 interventions - of which Fecal microbiota transplant (FMT) is the first listed.
NCT02465463 reports 1 study location spanning 1 distinct geographic area - top geographies include Georgia.
Frequently Asked Questions
What is clinical trial NCT02465463 about?
NCT02465463 is a clinical study titled "Early FMT for C.Difficile". Clostridium difficile infection (CDI) has increased worldwide in both frequency and severity. It is the leading cause of hospital acquired infection in developed countries and has been associated with at least 14,000 deaths per year in the United States. With 3 million cases/ year, the annual cost f...
What is the current status of trial NCT02465463?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2015-06. Estimated completion is 2016-11.
What conditions does trial NCT02465463 study?
This clinical trial studies the following conditions: Clostridium Difficile.
What interventions are being tested in trial NCT02465463?
The interventions under investigation include: Fecal microbiota transplant (FMT) (PROCEDURE), flexible sigmoidoscopy (DEVICE).
Who is sponsoring clinical trial NCT02465463?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02465463 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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