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NCT00967096 · ClinicalTrials.gov registry record · Phase 1
Rifaximin for Preventing Acute Graft Versus Host Disease (AGVHD)
A Phase 1 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT00967096: Completed Phase 1 study, sponsored by Emory University.
NCT00967096 is a Phase 1 study that has completed, run by Emory University. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00967096, a Phase 1 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
Acute graft versus host disease is a frequent and often life threatening complication of allogeneic blood and marrow transplantation. The bacteria that normally reside in the intestine play a critical role in its development. Injury to the lining of the bowel that results from the high dose chemotherapy or radiation that transplant patients receive during the week preceding the transplant allows the bacteria to invade the intestines and spread to nearby lymph nodes. This, in turn, causes inflammation which has been shown to promote GVHD. Both pre-clinical and clinical research has demonstrated that oral antibiotics can prevent graft versus host disease by inhibiting these gut bacteria. Rifaximin has several features that suggest it could be effective in preventing GVHD. Rifaximin prophylaxis might also provide an added benefit by protecting highly immunocompromised transplant patients from severe bacterial infections. This pilot trial will allow the investigators to determine the feasibility of using Rifaximin for prevention of GVHD and infection in patients undergoing allogeneic blood and marrow transplantation. The preliminary results will be used to plan a more definitive trial.
Interventions
- DRUG Rifaximin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2007-04 |
| Est. Completion | 2009-04 |
| Phase | Phase 1 |
What the finished NCT00967096 record still lists
NCT00967096 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 1 intervention - of which Rifaximin is the first listed.
NCT00967096 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00967096 about?
NCT00967096 is a clinical study titled "Rifaximin for Preventing Acute Graft Versus Host Disease (AGVHD)". Acute graft versus host disease is a frequent and often life threatening complication of allogeneic blood and marrow transplantation. The bacteria that normally reside in the intestine play a critical role in its development. Injury to the lining of the bowel that results from the high dose chemothe...
What is the current status of trial NCT00967096?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2007-04. Estimated completion is 2009-04.
What interventions are being tested in trial NCT00967096?
The interventions under investigation include: Rifaximin (DRUG).
Who is sponsoring clinical trial NCT00967096?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00967096's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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