The Effectiveness of Lactobacillus Plantarum (LBP) in Preventing Acute Graft-Versus-Host Disease (GvHD) in Children Undergoing Alternative Hematopoietic Progenitor Cell Transplantation (HCT)
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.
- 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
- 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
KeywordsLactobacillus Plantarum, acute graft disease, donor stem cell transplant, Hematopoietic cell transplantation
Principal InvestigatorWilliam Slayton, M.D.
Sponsoring GroupDepartment of Pediatrics
Begin a new search for other research studies
Studies listed on this site have been approved by a UF Institutional Review Board (IRB), which works to ensure the welfare and rights of research participants as required by federal regulations. Study listings are provided by the UF Clinical and Translational Science Institute in collaboration with UF research teams and the UF IRBs.