Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Donor Human Milk in Young Children Receiving Bone Marrow Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02470104
Recruitment Status : Completed
First Posted : June 12, 2015
Last Update Posted : June 26, 2018
Sponsor:
Collaborator:
Prolacta Bioscience
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 microbiota in children receiving human milk, with those receiving conventional feeding.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Randomized Study of Enteral Donor Human Milk in Young Children Receiving Bone Marrow Transplantation
Study Start Date : March 2015
Actual Primary Completion Date : May 25, 2017
Actual Study Completion Date : May 4, 2018

Resource links provided by the National Library of Medicine


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.
Biological: 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.



Primary Outcome Measures :
  1. Percentage of lactobacillales [ Time Frame: 21 days after transplant ]
    Bar chart to indicate percentage of lactobacillales in stool samples.


Secondary Outcome Measures :
  1. Pro-inflammatory cytokine level [ Time Frame: 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.

  2. Incidence of bacteremia [ Time Frame: though 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 4 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): NCT02470104


Locations
Layout table for location information
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Prolacta Bioscience
Investigators
Layout table for investigator information
Principal Investigator: Stella Davies, MB.BS, PhD, MRCP Children's Hospital Medical Center, Cincinnati

Layout table for additonal information
Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT02470104     History of Changes
Other Study ID Numbers: 2014-4127
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018

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