Donor Human Milk in Young Children Receiving Bone Marrow Transplantation

Not Applicable

Completed

• Conditions: Bone Marrow Transplant - Autologous or Allogeneic
• Interventions: Dietary Supplement: Breastmilk

• Registration Number: NCT02470104
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief 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.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-04-01
• Study First Submitted QC: 2015-06-10
• Study First Posted: 2015-06-12
• Primary Completion: 2017-05-25
• Study Completion: 2018-05-04
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-18
• Last Update Posted: 2020-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enteral Donor Breastmilk	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.

Primary Outcome Measures

Name	Time	Method
Percentage of lactobacillales	21 days after transplant	Bar chart to indicate percentage of lactobacillales in stool samples.

Secondary Outcome Measures

Name	Time	Method
Pro-inflammatory cytokine level	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.
Incidence of bacteremia	though day 14 post transplant	Frequency of bacterial sepsis to be compared against controls.
Incidence of graft versus host disease (GVHD)	through study course; approximately one year	Frequency of GVHD will be compared to controls.

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States