Donor Human Milk in Young Children Receiving Bone Marrow Transplantation

August 18, 2020 updated by: Children's Hospital Medical Center, Cincinnati

A Randomized Study of Enteral 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enteral Donor Breastmilk
  • Donor milk will be pasteurized prior to use.
  • Given orally or by nasogastric (NG) or nasojejunal (NJ) tube.
  • Feeding will be supervised and will be advanced as quickly as tolerated with a goal of providing 40-50% of nutritional needs from the donor milk.
  • It is recognized that the volume of enteral feeds will need to be adjusted per patient tolerance.
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.
No Intervention: Control
• Children randomized to the control arm will receive standard enteral or parenteral nutrition per standard clinical practice, supervised by a registered dietician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of lactobacillales
Time Frame: 21 days after transplant
Bar chart to indicate percentage of lactobacillales in stool samples.
21 days after transplant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
weekly during study course; up to approximately one year
Incidence of bacteremia
Time Frame: though day 14 post transplant
Frequency of bacterial sepsis to be compared against controls.
though day 14 post transplant
Incidence of graft versus host disease (GVHD)
Time Frame: through study course; approximately one year
Frequency of GVHD will be compared to controls.
through study course; approximately one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

Prolacta Bioscience

Investigators

  • Principal Investigator: Stella Davies, MB.BS, PhD, MRCP, Children's Hospital Medical Center, Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

May 25, 2017

Study Completion (Actual)

May 4, 2018

Study Registration Dates

First Submitted

April 1, 2015

First Submitted That Met QC Criteria

June 10, 2015

First Posted (Estimate)

June 12, 2015

Study Record Updates

Last Update Posted (Actual)

August 20, 2020

Last Update Submitted That Met QC Criteria

August 18, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2014-4127

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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