Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
NCT Number: NCT04111471
This study will look at the effect of the prebiotic inulin compared to placebo on children undergoing stem cell transplant.
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Notify Me2 year–18 year
All sexes
Interventional
Not applicable
Chicago, Illinois, 60611, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Enrolled patients will receive 10 grams of inulin daily for 21 days
Other names: inulin
Enrolled patients will receive 5.6 grams of placebo powder daily for 21 days
Other names: Maltodextrin
Time frame: Change of baseline alpha and beta bacterial diversity at 100 days after transplant
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 in baseline SCFA levels in stool at 100 days after transplant
Compare the effect of oral inulin vs. placebo on SCFA levels in the stool 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
Determine the impact of inulin intake vs. placebo on the prevalence of genes associated with antibiotic resistance of children undergoing hematopoietic stem cell transplant
Ann & Robert H Lurie Children's Hospital of Chicago
Other
The Use of Inulin to Prevent Dysbiosis in Pediatric Hematopoietic Stem Cell Transplant Recipients
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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