Bone Marrow Transplant - Autologous or Allogeneic
Conditions
Keywords
children, bone marrow transplant, autologous, allogeneic, breastmilk, hematopoietic stem cell transplantation (HSCT)
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.
Interventions
DIETARY_SUPPLEMENTBreastmilk
* 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.
Sponsors
Prolacta Bioscience
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 4 Years
Healthy volunteers
No
Inclusion criteria
* Children less than 5 years old receiving transplant (autologous or allogeneic) * Parents must give informed consent
Exclusion criteria
* Failure to meet inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of lactobacillales | 21 days after transplant | Bar chart to indicate percentage of lactobacillales in stool samples. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed