An interventional study of Breastmilk in Bone Marrow Transplant - Autologous or Allogeneic, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 1 site in United States. Open to participants aged Up to 4 Years. Per ClinicalTrials.gov, last updated 2020-08-20.
Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Supportive care
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.
Children's Hospital Medical Center, Cincinnati is the lead sponsor of 661 studies on the registry; 134 are open to participants now.
Of its 54 completed or terminated interventional studies of FDA-regulated products, 30 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
* Donor milk will be pasteurized prior to use. * Given orally or by nasogastric (NG) or nasojejunal (NJ) tube. * Feeding will be supervised and will be advanced as quickly as tolerated with a goal of providing 40-50% of nutritional needs from the donor milk. * It is recognized that the volume of enteral feeds will need to be adjusted per patient tolerance.
Dietary Supplement: Breastmilk
• Children randomized to the control arm will receive standard enteral or parenteral nutrition per standard clinical practice, supervised by a registered dietician.
* 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.
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
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Children's Hospital Medical Center, Cincinnati