Human Breastmilk in Children Receiving a Bone Marrow Transplant

Not Applicable

Completed

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

• Registration Number: NCT02025478
• 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 micobiota in children receiving human milk, with those receiving conventional feeding.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-09-05
• Primary Completion: 2013-10
• Study First Submitted QC: 2013-12-30
• Study Completion: 2014-01
• Study First Posted: 2014-01-01
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-18
• Last Update Posted: 2020-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Enteral Donor Breastmilk	Breastmilk	* Donor breast 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 charts to indicate types and percentage of bacteria in stool samples - will quantify the bacterial diversity using the Shannon index and bacterial chaos using the Bray-Curtis time index.

Secondary Outcome Measures

Name	Time	Method
Levels of pro-inflammatory cytokines	Weekly during study course; up to approximately one year	Mean fold increase above baseline for each cytokine will be calculated and compared to controls
Incidence of graft versus host disease (GVHD)	through study course; approximately one year	Frequency of GVHD will be compared to controls
Incidence of bacteremia	through day 14 post transplant	Frequency of bacterial sepsis to be compared against controls

Trial Locations

Locations (1)

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