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Human Breastmilk in Children Receiving a Bone Marrow Transplant (MILK)

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ClinicalTrials.gov Identifier: NCT02025478
Recruitment Status : Completed
First Posted : January 1, 2014
Last Update Posted : August 29, 2016
Sponsor:
Collaborator:
Mothers' Milk Bank Northeast
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Bone Marrow Transplant- Autologous or Allogeneic Biological: Breastmilk Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pilot Study of Enteral Donor Human Milk in Young Children Receiving Bone Marrow Transplantation
Study Start Date : May 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Enteral Donor 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.
Biological: Breastmilk
  • A registered dietician will supervise milk provision, and additional calories will be provided by addition of the supplement Prolacta. To make 28 kcal/oz milk, 40 ml of Prolacta will be mixed with 60 ml human milk to make a total volume of 100 ml.
  • 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.




Primary Outcome Measures :
  1. Percentage of lactobacillales [ Time Frame: 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 :
  1. Levels of pro-inflammatory cytokines [ Time Frame: Weekly during study course; up to approximately one year ]
    Mean fold increase above baseline for each cytokine will be calculated and compared to controls

  2. Incidence of bacteremia [ Time Frame: through day 14 post transplant ]
    Frequency of bacterial sepsis to be compared against controls

  3. Incidence of graft versus host disease (GVHD) [ Time Frame: through study course; approximately one year ]
    Frequency of GVHD will be compared to controls



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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02025478


Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Mothers' Milk Bank Northeast
Investigators
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Principal Investigator: Stella Davies, MBBS, PhD, MRCP Children's Hospital Medical Center, Cincinnati

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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT02025478     History of Changes
Other Study ID Numbers: 2013-2412
First Posted: January 1, 2014    Key Record Dates
Last Update Posted: August 29, 2016
Last Verified: August 2016

Keywords provided by Children's Hospital Medical Center, Cincinnati:
children
bone marrow transplant
autologous
allogeneic
breastmilk
hematopoietic stem cell transplantation (HSCT)