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

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: Bone Marrow Transplant - Autologous or Allogeneic
• Intervention / Treatment: Dietary supplement: Breastmilk

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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	Frequency of bacterial sepsis to be compared against controls.	though day 14 post transplant
Incidence of graft versus host disease (GVHD)	Frequency of GVHD will be compared to controls.	through study course; approximately one year

Collaborators and Investigators

• 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

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: children; autologous; breastmilk; allogeneic; bone marrow transplant; hematopoietic stem cell transplantation (HSCT)
• 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