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 micobiota in children receiving human milk, with those receiving conventional feeding.
Interventions
DIETARY_SUPPLEMENTBreastmilk
* A registered dietician will supervise milk provision, and additional calories will be provided by addition of the supplement Prolacta. To make 28 kcal/oz milk, 40 ml of Prolacta will be mixed with 60 ml human milk to make a total volume of 100 ml. * 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
Mothers' Milk Bank Northeast
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 5 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 charts to indicate types and percentage of bacteria in stool samples - will quantify the bacterial diversity using the Shannon index and bacterial chaos using the Bray-Curtis time index. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Levels of pro-inflammatory cytokines | Weekly during study course; up to approximately one year | Mean fold increase above baseline for each cytokine will be calculated and compared to controls |
| Incidence of bacteremia | through 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