The Effectiveness of Lactobacillus Plantarum (LBP) in Preventing Acute Graft-Versus-Host Disease (GvHD) in Children Undergoing Alternative Hematopoietic Progenitor Cell Transplantation (HCT)

Purpose

This randomized phase III trial studies how well Lactobacillus plantarum works in preventing acute graft versus host disease in children undergoing donor stem cell transplant. Lactobacillus plantarum may help prevent the development of gastrointestinal graft versus host disease in children, adolescents, and young adults undergoing donor stem cell transplant.

Inclusion Criteria:

  • Patient must have a diagnosis that is managed with an alternative donor allogeneic hematopoietic cell transplant
  • Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0 or 1 (>= 70% for Karnofsky/Lansky); use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
  • Hematopoietic cell transplant (HCT)
  • No previous history of HCT or other cellular therapy (e.g., chimeric antigen receptor [CAR]-T cells, donor lymphocyte infusions)
  • Patient must be receiving cells from a first alternative donor defined as one of the following:
  • Unrelated donor with a complete human leukocyte antigen (HLA) match or a 1 or 2 HLA mismatch
  • Related donor with a 1 or 2 HLA mismatch

Exclusion Criteria:

  • Patient plans on receiving stem cells from a matched (8/8) related donor
  • Patient plans on receiving stem cells from a donor who has a 3 or more HLA mismatch
  • Patient has used a probiotic dietary supplement within the previous 30 days of enrollment; (consumption of yogurt products is allowed)
  • Patient has a history of severe GI tract insult including but not limited to previous bowel perforation, grade 4 neutropenic colitis or typhlitis, inflammatory bowel syndrome, short small bowel syndrome (Crohn’s disease, ulcerative colitis) or history of bowel resection
  • Patient has a medical, psychiatric or social issue that would compromise patient safety or compliance with protocol therapy, or interfere with consent, study participation, follow up, or interpretation of study results
  • Female patients who are pregnant are not eligible; women of childbearing potential require a negative pregnancy test prior to enrollment
  • Patient has diarrhea at the time of enrollment which is Clostridium difficile toxin positive
  • Patient is receiving antibiotic therapy for an active infection
  • Patient is allergic to the third or fourth generation celphalosporins, carbapenem, or aminoglycosides which are used to empirically treat LBP bacteremia

    Age

    18 and under
    18 to 65

    Keywords

    Lactobacillus Plantarum, acute graft disease, donor stem cell transplant, Hematopoietic cell transplantation

    Principal Investigator

    William Slayton, M.D.

    Sponsoring Group

    Department of Pediatrics

    Department

    MD-PEDS-HEMATOLOGY

    Contact Information

    slaytwb@peds.ufl.edu

    352.273.9120


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