title: The safety and feasibility of probiotics in children and adolescents undergoing hematopoietic cell transplantation.
abstract: Hematopoietic cell transplantation (HCT) has become a standard treatment for many adult and pediatric conditions. Emerging evidence suggests that perturbations in the microbiota diversity increase recipients' susceptibilities to gut-mediated conditions such as diarrhea, infection and acute GvHD. Probiotics preserve the microbiota and may minimize the risk of developing a gut-mediated condition; however, their safety has not been evaluated in the setting of HCT. We evaluated the safety and feasibility of the probiotic, Lactobacillus plantarum (LBP), in children and adolescents undergoing allogeneic HCT. Participants received once-daily supplementation with LBP beginning on day -8 or -7 and continued until day +14. Outcomes were compliance with daily administration and incidence of LBP bacteremia. Administration of LBP was feasible with 97% (30/31, 95% confidence interval (CI) 83-100%) of children receiving at least 50% of the probiotic dose (median 97%; range 50-100%). We did not observe any case of LBP bacteremia (0% (0/30) with 95% CI 0-12%). There were not any unexpected adverse events related to LBP. Our study provides preliminary evidence that administration of LBP is safe and feasible in children and adolescents undergoing HCT. Future steps include the conduct of an approved randomized, controlled trial through Children's Oncology Group.
authors.affiliation: Division of Pediatric Hematology/Oncology/Stem Cell Transplant, Columbia University Medical Center, New York, NY, USA.|Institute of Human Nutrition, College of Physicians and Surgeons, Columbia University Medical Center, New York, NY, USA.
authors.forename: E J
authors.initials: EJ
authors.lastname: Ladas
authors.affiliation: Division of Pediatric Hematology/Oncology/Stem Cell Transplant, Columbia University Medical Center, New York, NY, USA.
authors.forename: M
authors.initials: M
authors.lastname: Bhatia
authors.affiliation: Children's Oncology Group, Acadia, CA, USA.|Department of Preventive Medicine, University of Southern California, Los Angeles, CA, USA.
authors.forename: L
authors.initials: L
authors.lastname: Chen
authors.affiliation: Division of Hematology/Oncology, Nemours Children's Health System, Jacksonville, FL, USA.
authors.forename: E
authors.initials: E
authors.lastname: Sandler
authors.affiliation: Blood and Bone Marrow Transplantation, All Children's Hospital John Hopkins Medicine, St Petersburg, FL, USA.
authors.forename: A
authors.initials: A
authors.lastname: Petrovic
authors.affiliation: Division of Pediatric Infectious Diseases, All Children's Hospital, John Hopkins Medicine, St Petersburg, FL, USA.
authors.forename: D M
authors.initials: DM
authors.lastname: Berman
authors.affiliation: All Children's Hospital, John Hopkins Medicine, St Petersburg, FL, USA.
authors.forename: F
authors.initials: F
authors.lastname: Hamblin
authors.affiliation: All Children's Hospital, John Hopkins Medicine, St Petersburg, FL, USA.
authors.forename: M
authors.initials: M
authors.lastname: Gates
authors.affiliation: Division of Pediatric Hematology/Oncology/Stem Cell Transplant, Columbia University Medical Center, New York, NY, USA.
authors.forename: R
authors.initials: R
authors.lastname: Hawks
authors.affiliation: Division of Haematology/Oncology, The Hospital for Sick Kids, Toronto, Ontario, Canada.
authors.forename: L
authors.initials: L
authors.lastname: Sung
authors.affiliation: Department of Blood and Marrow Transplantation, Moffitt Cancer Center, Tampa, FL, USA.
authors.forename: M
authors.initials: M
authors.lastname: Nieder
mesh_terms: D000293:Adolescent; D000328:Adult; D064591:Allografts; D002648:Child; D002675:Child, Preschool; D003967:Diarrhea / Q000209:etiology / Q000517:prevention & control*; D005260:Female; D006086:Graft vs Host Disease / Q000209:etiology / Q000517:prevention & control*; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D007223:Infant; D007410:Intestinal Diseases / Q000209:etiology / Q000517:prevention & control*; D048191:Lactiplantibacillus plantarum; D008297:Male; D010865:Pilot Projects; D019936:Probiotics / Q000008:administration & dosage* / Q000009:adverse effects