NCT02025478

Human Breastmilk in Children Receiving a Bone Marrow Transplant

A Pilot Study of Enteral Donor Human Milk in Young Children Receiving Bone Marrow Transplantation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 5 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 micobiota in children receiving human milk, with those receiving conventional feeding.

Conditions

• Bone Marrow Transplant- Autologous or Allogeneic

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Breastmilk	* 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.

Timeline

• Start date: 2013-05-01
• Primary completion: 2013-10-01
• Completion: 2014-01-01
• First posted: 2014-01-01
• Last updated: 2020-08-20

Locations

1 site across 1 country: United States