Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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. The trial reports 1 study location across 1 state.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02127398
The ClinicalTrials.gov registry entry for NCT02127398 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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
Similar trials for Clostridium Difficile Colitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.