A Randomized Trial Testing a Probiotic Enteric Regimen for Easing Complications of Transplant (Randomized PERFECT Trial)

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A Randomized Trial Testing a Probiotic Enteric Regimen for Easing Complications of Transplant (Randomized PERFECT Trial)

Primary: To determine if allogeneic hematopoietic stem cell transplant patients treated with a probiotic containing diet compared to those not assigned to receive probiotic have a lower incidence of grade 1 upper GI or grade 2-4 lower GI acute GVHD using CIBMTR scoring than those not prescribed a probiotic.
Secondary: To determine if allogeneic hematopoietic stem cell transplant patients treated with a probiotic-containing diet compared to those not assigned to receive a probiotic have (a) lower rate of organ-specific GVHD; (b) lower rate of moderate to severe chronic GVHD at 6 months and 1 year post transplant; (c) shorter duration of immunosuppressive therapy; (d) lower rate of bacterial and/or opportunistic infection.

Protocol Number021202
Principal InvestigatorRoger Strair
PhasePhase II
ScopeLocal
Applicable Disease SitesLymphoid Leukemia
Myeloid and Monocytic Leukemia
Leukemia, not otherwise specified
Other Hematopoietic
Therapies InvolvedTherapy (NOS)
Drugs InvolvedCulturelle DS (Lactobacillus GG)
Participating InstitutionsRutgers Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.