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NCT02127398 · ClinicalTrials.gov registry record · Phase 2
Stool Transplants to Treat Refractory Clostridium Difficile Colitis
A Phase 2 study of Clostridium Difficile Colitis, sponsored by Duke University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 77
- Enrollment target
- 1
- Study location
NCT02127398: Recruiting Phase 2 study of Clostridium Difficile Colitis, sponsored by Duke University.
NCT02127398 is a Phase 2 study of Clostridium Difficile Colitis that is actively recruiting participants, run by Duke University. The registered enrollment target is 77 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (42% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02127398, a Phase 2 study of Clostridium Difficile Colitis, is actively recruiting participants, sponsored by Duke University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 77 participants
- Enrollment target
- 1
- Study location
Study Summary
It has been shown that restoration of the normal makeup of the bowel bacterial population is the most effective way to treat recurrent colitis due to Clostridium difficile. Restoration of the normal bowel bacterial population is best done by transplanting stool from a healthy donor. The investigators wish to transplant stool from healthy donors to treat recurrent C. difficile colitis by incorporating the stool into capsules that are administered by the oral route.
Primary Outcome
Patients will be followed 1, 7, 28, and 180 days after the treatment and success will be defined as resolution of C. difficile infection without recurrence within a six-month time period. Patients will be assessed by interview and physical exam. Any patients with suspected persisting/recurring C. difficile colitis will undergo further evaluation with a repeat stool C. difficile toxin assay.
Conditions Studied
Interventions
- BIOLOGICAL fecal microbiota
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2016-04 |
| Est. Completion | 2026-05 |
| Phase | Phase 2 |
What NCT02127398 shows while recruiting
NCT02127398 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (42% lower).
The record links to 1 condition, with Clostridium Difficile Colitis appearing as the primary indexed condition, and to 1 intervention - of which fecal microbiota is the first listed.
NCT02127398 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT02127398 about?
NCT02127398 is a clinical study titled "Stool Transplants to Treat Refractory Clostridium Difficile Colitis". It has been shown that restoration of the normal makeup of the bowel bacterial population is the most effective way to treat recurrent colitis due to Clostridium difficile. Restoration of the normal bowel bacterial population is best done by transplanting stool from a healthy donor. The investigator...
What is the current status of trial NCT02127398?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 77 participants. The study started on 2016-04. Estimated completion is 2026-05.
What conditions does trial NCT02127398 study?
This clinical trial studies the following conditions: Clostridium Difficile Colitis.
What interventions are being tested in trial NCT02127398?
The interventions under investigation include: fecal microbiota (BIOLOGICAL).
Who is sponsoring clinical trial NCT02127398?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02127398 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02127398's enrollment target sits among peer trials
77 891st of 2000 higher than 1,109 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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