ACCL1633, The Effectiveness of Lactobacillus plantarum in Preventing Acute Graft-versus-Host Disease (GvHD) in Children undergoing Alternative Hematopoietic Progenitor Cell Transplantation (HCT)
Sandeep Batra, MD
Primary Investigator
Overview
The purpose of this study is to find out if the probiotic Lactobacillus plantarum (LBP) will prevent the development of GI aGvHD in children, adolescents, and young adults undergoing alternative alloHCT.
Eligibility
You may be eligible for this study if you meet the following criteria:
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Conditions:
Graft-versus-Host Disease
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Age: Between 2 Years - 25 Years
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Gender: All
Inclusion Criteria
Patient must have a diagnosis that is managed with an alternative donor allogenic hematopoietic cell transplant
No previous history of HCT or other cellular therapy
Must be receiving cells from a first alternative donor
Exclusion Criteria
Patient plans on receiving cells from a matched (8/8) related donor
Patient plans on receiving stem cells from a donor who has a 3 or moe HLA mismatch
Patient has used a probiotic dietary supplement within 30 days prior to enrollment (consumption of yogurt products is allowed)
Patient has a history of severe GI tract insult, including but not limited to previous bowel peforation, Grade 4 neutropenic colitic or typhlitis, inflammatory bowel syndrome, short small bowel syndrome (Crohn's disease, ulcerative colitis) or history of bowel resection
Female patients who are pregnant
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 cephalosporins, carbapenems, or aminoglycosides which are used to empirically treat LBP bacteremia