NCT00967096

Rifaximin for Preventing Acute Graft Versus Host Disease (AGVHD)

Rifaximin for Preventing Acute Graft Versus Host Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malignancy
• Bone Marrow Transplantation

Interventions

Type	Name	Description
DRUG	Rifaximin	Rifaximin for Bone marrow transplant patients

Timeline

• Start date: 2007-04-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2009-08-27
• Last updated: 2013-11-27

Locations

2 sites across 1 country: United States