A Pilot Study of Enteral Donor Human Milk in Young Children Receiving Bone Marrow Transplantation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 11
- Locations
- 2
- Primary Endpoint
- Percentage of lactobacillales
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- — to 5 Years (Child)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Percentage of lactobacillales
Time Frame: 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 Outcomes
- Levels of pro-inflammatory cytokines(Weekly during study course; up to approximately one year)
- Incidence of graft versus host disease (GVHD)(through study course; approximately one year)
- Incidence of bacteremia(through day 14 post transplant)