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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 is a Phase 1 study that has completed, run by Emory University. The registered enrollment target is 20 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00967096
The ClinicalTrials.gov registry entry for NCT00967096 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Rifaximin is the first listed.
NCT00967096 reports 0 study locations.
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.
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