Donor Human Milk in Young Children Receiving Bone Marrow Transplantation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bone Marrow Transplant - Autologous or Allogeneic

Intervention / Treatment
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* Dietary Supplement: Breastmilk


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enteral Donor Breastmilk<br>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<br>* 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.<br>|
| No Intervention: Control<br>• 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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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children, bone marrow transplant, autologous, allogeneic, breastmilk, hematopoietic stem cell transplantation (HSCT)