- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02025478
Human Breastmilk in Children Receiving a Bone Marrow Transplant (MILK)
August 18, 2020 updated by: Children's Hospital Medical Center, Cincinnati
A Pilot Study of Enteral Donor Human Milk in Young Children Receiving Bone Marrow Transplantation
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
11
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 5 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Enteral Donor Breastmilk
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
21 days after transplant
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Weekly during study course; up to approximately one year
|
Incidence of bacteremia
Time Frame: through day 14 post transplant
|
Frequency of bacterial sepsis to be compared against controls
|
through day 14 post transplant
|
Incidence of graft versus host disease (GVHD)
Time Frame: through study course; approximately one year
|
Frequency of GVHD will be compared to controls
|
through study course; approximately one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Actual)
October 1, 2013
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
September 5, 2013
First Submitted That Met QC Criteria
December 30, 2013
First Posted (Estimate)
January 1, 2014
Study Record Updates
Last Update Posted (Actual)
August 20, 2020
Last Update Submitted That Met QC Criteria
August 18, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2013-2412
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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