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Rifaximin for Preventing Acute Graft Versus Host Disease

Phase 1
12 Years
Open (Enrolling)
Malignancy, Bone Marrow Transplantation

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Trial Information

Rifaximin for Preventing Acute Graft Versus Host Disease

Inclusion Criteria:

1. Patients must be at least 12 years old.

2. Patients will be eligible regardless of their type of disease (malignant or
non-malignant), type of donor (HLA matched related, mismatched related or unrelated
donors), type of hematopoietic cell source (unstimulated marrow, cytokine stimulated
marrow, cytokine stimulated peripheral blood or umbilical cord blood), or GVHD

3. Patients must receive a myeloablative or moderately intensive reduced intensity (at
least 8 mg/kg oral busulfan (or the equivalent IV dose), or at least 100 mg/m2 of
Melphalan , or at least 100 mg/kg of cyclophosphamide, or at least 500 cGy of TBI)
conditioning regimen.

Exclusion Criteria:

1. Age under 12 years.

2. Known hypersensitivity to rifaximin, or other rifamycin antimicrobial agents.

3. Minimally toxic conditioning regimen (e.g. low dose TBI based). Since these regimens
induce minimal myelosuppression and gut injury, patients receiving them probably
stand little to gain from antibiotic prophylaxis.

4. Patients with documented severe active infection (viral, bacterial, fungal,
protozoal) will not be eligible.

5. Patients with treatment unresponsive hematologic malignant diseases (based on an
assessment done within two weeks of the start of conditioning therapy).

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the feasibility of this approach; to gather preliminary data on the incidence of GVHD and other clinical outcomes; to obtain pre-clinical data on the serial plasma levels of three biologic markers- endotoxin, soluble IL-2 receptor and TNF.

Outcome Time Frame:

1 year after last patient enrolled

Safety Issue:


Principal Investigator

John Horan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University


United States: Institutional Review Board

Study ID:




Start Date:

April 2007

Completion Date:

April 2018

Related Keywords:

  • Malignancy
  • Bone Marrow Transplantation
  • rifaximin
  • acute graft versus host disease
  • bone marrow transplant
  • non-malignancy requiring BMT
  • Neoplasms
  • Graft vs Host Disease



Emory UniversityAtlanta, Georgia  30322
Children's Healthcare of AtlantaAtlanta, Georgia  30342