This study will look at the effect of the prebiotic inulin compared to placebo on children undergoing stem cell transplant.
Children enrolled in the study will receive either the prebiotic inulin or a placebo for 21 days during the study period. They will start taking the product seven days before transplant starts until 14 days after transplant. Stool will be collected twice weekly until thirty days after transplant or discharge, whichever occurs first. Stool samples will be sampled for metagenomic sequencing to identify the diversity of bacteria within the stool. They will also be analyzed for amount of short-chain fatty acid content (a breakdown product of inulin) as well as for presence of genes that confer antibiotic resistance. From 30 days after transplant until 100 days after transplant, two stool samples will be collected at regularly scheduled follow up appointments (near day 60 and day 100). No product (inulin or placebo) will be given during this time frame. The study period ends 100 days after transplant.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
5
Enrolled patients will receive 10 grams of inulin daily for 21 days
Enrolled patients will receive 5.6 grams of placebo powder daily for 21 days
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Change in alpha and beta bacterial diversity measures in stool
Compare the effect of oral inulin vs. placebo on alpha and beta bacterial diversity in the stool of children undergoing hematopoietic stem cell transplant
Time frame: Change of baseline alpha and beta bacterial diversity at 100 days after transplant
Change in Short Chain Fatty Acid (SCFA) levels in stool
Compare the effect of oral inulin vs. placebo on SCFA levels in the stool of children undergoing hematopoietic stem cell transplant
Time frame: Change in baseline SCFA levels in stool at 100 days after transplant
Bacterial Resistance genes in stool
Determine the impact of inulin intake vs. placebo on the prevalence of genes associated with antibiotic resistance of children undergoing hematopoietic stem cell transplant
Time frame: Measured at enrollment, on the day of transplant, 30 days after transplant, and near 100 days after transplant
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