lactobacillus rhamnosus gg in reducing incidence of graft-versus-host disease in patients who have undergone donor stem cell transplant

Conditions: Graft Versus Host Disease

Summary: this randomized pilot clinical trial studies lactobacillus rhamnosus gg in reducing incidence of graft-versus-host disease in patients who have undergone donor stem cell transplant. lactobacillus rhamnosus gg may be effective at preventing for graft-versus-host disease caused by a donor stem cell transplant.

primary objectives: i. to determine if hematopoietic stem cell transplant (hsct) patients treated with a probiotic (lactobacillus gg \[lactobacillus rhamnosus gg\])-containing diet compared to those not assigned to receive probiotic have a lower incidence of grade 1 upper gastrointestinal (gi) or grade 2-4 lower gi acute graft-versus-host disease (gvhd) (agvhd) using center for international blood and marrow transplant research (cibmtr) scoring than those not prescribed a probiotic. ii. to determine if hsct patients treated with a probiotic-containing diet compared to those not assigned to receive a probiotic have a: a) lower rate of organ-specific acute agvhd (intestinal tract, skin, liver); b) lower rate of moderate or severe chronic gvhd (national institutes of health \[nih\] consensus scoring) at 6 months and 1 year post transplant; c) shorter duration of immunosuppressive therapy (normalized for age and degree of human leukocyte antigen \[hla\] match); d) lower rate of bacterial and/or opportunistic infection. secondary objectives: i. to determine if allogeneic hematopoietic stem cell patients treated with a probiotic compared to those not assigned to receive a probiotic have differences in: a) composition and proportion of the major gut bacterial phylotypes in stool (to be analyzed for changes pre- and post-initiation of probiotics and for association with development of agvhd); b) measures of inflammation as assessed by cytokine or receptor production (interleukin \[il\]-6, il-8, tumor necrosis factor \[tnf\]-alpha, tnf-receptor 1, interferon-gamma, il-2r, il-10); c) qualitative measures of immune reconstitution as determined by sequential measurements of conventional t cells, regulatory t regulatory, b cells and natural killer (nk) cells; d) antibody class/subclass production; e) biomarkers associated with gvhd-elafin, regenerating islet-derived 3 alpha (reg3a), suppressor of tumorigenicity-2 (st2), hepatocyte growth factor (hgf); and/or urinary tryptophan metabolites; f) markers of gut barrier function including blood levels of endotoxin and microbial deoxyribonucleic acid (dna). outline: patients are randomized to 1 of 2 treatment arms. arm i: patients receive lactobacillus rhamnosus gg orally (po) once daily (qd) for 1 year. arm ii: patients receive no intervention.

Eligibility criteria:
inclusion criteria: * able to sign informed consent * undergoing allogeneic hsct from a related or unrelated donor * hematopoietic engraftment as evidenced by recovery of the absolute neutrophil count to greater than 500/mm\^3 for \> 3 days without filgrastim (g-csf) support and within 40 days of transplant (i.e. complete blood counts \[cbcs\] obtained 3 or more days apart while off of g-csf must demonstrate an absolute neutrophil count \> 500/mm\^3); if absolute neutropenia is not achieved due to a non-myeloablative transplant, the patient can be enrolled on day +21 to +40 * eastern cooperative oncology group (ecog) performance status of 0-2 exclusion criteria: * evidence of gvhd at the time of enrollment as assessed clinically * serum creatinine greater than 3.0 * aspartate aminotransferase (ast) or alanine aminotransferase (alt) greater than 3 times the upper limit of normal * total bilirubin greater than 2 times upper limit of normal * prior use of probiotics within 3 months prior to enrollment * inability to take medications by mouth * prior history of inflammatory bowel disease or other chronic diarrheal illness * prior history of hypersensitivity to milk proteins * active clostridium difficile infection or on prophylactic or tapering antibiotics for clostridium difficile infection