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OpenTrials
Completed

NCT Number: NCT02470104

Donor Human Milk in Young Children Receiving Bone Marrow Transplantation

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.

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Key information

Conditions

Bone Marrow Transplant - Autologous or Allogeneic

Age range

Up to 4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breastmilk

Dietary Supplement
  • 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.

Primary outcomes

  1. Percentage of lactobacillales

    Time frame: 21 days after transplant

    Bar chart to indicate percentage of lactobacillales in stool samples.

Secondary outcomes

  1. Pro-inflammatory cytokine level

    Time frame: 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.

  2. Incidence of bacteremia

    Time frame: though day 14 post transplant

    Frequency of bacterial sepsis to be compared against controls.

  3. Incidence of graft versus host disease (GVHD)

    Time frame: through study course; approximately one year

    Frequency of GVHD will be compared to controls.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • Prolacta Bioscience

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Jun 12, 2015
Registry last updated
Aug 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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