ACCL1633, The Effectiveness of Lactobacillus plantarum in Preventing Acute Graft-versus-Host Disease (GvHD) in Children undergoing Alternative Hematopoietic Progenitor Cell Transplantation (HCT)
Investigating Probiotics for Preventing Gastrointestinal Complications in Transplant Patients
Brief description of study.
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 of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Graft-versus-Host Disease
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Age: 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
This study investigates whether the probiotic Lactobacillus plantarum can prevent gastrointestinal graft-versus-host disease (GI aGvHD) in children, adolescents, and young adults who are undergoing an alternative allogenic hematopoietic cell transplant (alloHCT). GI aGvHD is a condition where the donated cells attack the gastrointestinal tract of the recipient, causing inflammation and damage.
Participants will be given either the probiotic Lactobacillus plantarum or a placebo. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine. The study will monitor the development of GI aGvHD and other health outcomes in the participants.
- Who can participate: Children, adolescents, and young adults undergoing an alternative donor allogenic hematopoietic cell transplant can participate. Participants must not have a history of previous hematopoietic cell transplant or cellular therapy and must be receiving cells from a first alternative donor.
- Study details: Participants will receive either the probiotic Lactobacillus plantarum or a placebo. The study will track the health and development of GI aGvHD in participants.
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