ACCL1633, The Effectiveness of Lactobacillus plantarum in Preventing Acute Graft-versus-Host Disease (GvHD) in Children undergoing Alternative Hematopoietic Progenitor Cell Transplantation (HCT)

S
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:

  • Conditions:
    Graft-versus-Host Disease
  • Age: Between 2 Years - 25 Years
  • 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

Updated on 20 Nov 2022. Study ID: 1805599189 (PHO-COG-PRADHAN-ACCL1633)

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