Trials / Completed
CompletedNCT02470104
Donor Human Milk in Young Children Receiving Bone Marrow Transplantation
A Randomized Study of Enteral Donor Human Milk in Young Children Receiving Bone Marrow Transplantation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- Children's Hospital Medical Center, Cincinnati · Academic / Other
- Sex
- All
- Age
- 4 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Breastmilk | * 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. |
Timeline
- Start date
- 2015-03-01
- Primary completion
- 2017-05-25
- Completion
- 2018-05-04
- First posted
- 2015-06-12
- Last updated
- 2020-08-20
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02470104. Inclusion in this directory is not an endorsement.