The investigators hypothesize that children receiving human milk will maintain a greater diversity of helpful bacteria in their gut and have lower levels of inflammatory proteins in the blood compared with children not receiving human milk.
The investigators hypothesize that the gut microbiota during bone marrow transplant could be influenced by administration of enteral donor breast milk. This study will attempt to address this hypothesis, by feeding donor breast milk to young children undergoing transplant, and serially comparing the gut microbiota in children receiving human milk, with those receiving conventional feeding.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
42
* A registered dietician will supervise milk provision. * If a nursing mother enrolls on the study, maternal and not donor milk will be given in the maximum volume possible with Prolacta supplementation if clinically indicated and recommended by the registered dietician.
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Percentage of lactobacillales
Bar chart to indicate percentage of lactobacillales in stool samples.
Time frame: 21 days after transplant
Pro-inflammatory cytokine level
Mean fold increase above baseline for the cytokine will be calculated and compared to control. Value will be tested for statistical significance using the Wilcoxon Rank Sum test.
Time frame: weekly during study course; up to approximately one year
Incidence of bacteremia
Frequency of bacterial sepsis to be compared against controls.
Time frame: though day 14 post transplant
Incidence of graft versus host disease (GVHD)
Frequency of GVHD will be compared to controls.
Time frame: through study course; approximately one year
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