Donor Human Milk in Young Children Receiving Bone Marrow Transplantation
- Conditions
- Bone Marrow Transplant - Autologous or Allogeneic
- Registration Number
- NCT02470104
- Lead Sponsor
- Children's Hospital Medical Center, Cincinnati
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
- Children less than 5 years old receiving transplant (autologous or allogeneic)
- Parents must give informed consent
- Failure to meet inclusion criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Percentage of lactobacillales 21 days after transplant Bar chart to indicate percentage of lactobacillales in stool samples.
- Secondary Outcome Measures
Name Time Method Pro-inflammatory cytokine level weekly during study course; up to approximately one year 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.
Incidence of bacteremia though day 14 post transplant Frequency of bacterial sepsis to be compared against controls.
Incidence of graft versus host disease (GVHD) through study course; approximately one year Frequency of GVHD will be compared to controls.
Trial Locations
- Locations (1)
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Cincinnati Children's Hospital Medical Center🇺🇸Cincinnati, Ohio, United States