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
Other Hematopoietic
Non-Hodgkin's Lymphoma
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.