Back to resultsHuman Breastmilk in Young Children With Norovirus Infection of the Gut
Primary Purpose
Norovirus Infections
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Donor Breastmilk
Sponsored by
About this trial
This is an interventional supportive care trial for Norovirus Infections focused on measuring stem cell transplant, human breastmilk
Eligibility Criteria
Inclusion Criteria:
- Children with at least two stool samples taken at least 7 days apart that are positive for norovirus
- Child has an underlying disease or has received immunosuppressive medication or chemotherapy such that clearance of norovirus is expected to be impaired.
Exclusion Criteria:
- The presence of other pathogens causing diarrhea that have specific treatments does not preclude enrollment. However, specific treatment should be offered in addition to human milk.
Sites / Locations
- Cincinnati Children's Hospital Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Donor Breastmilk
Arm Description
Donated human milk is subjected to pasteurization prior to use. Milk consumption is to be overseen by a Registered Dietician. Oral or enteral milk feeding will begin at 180 ml/day and will be advanced as quickly as tolerated to a goal of 360 ml/day for 6 weeks. If symptoms and stool tests for norovirus do not improve after 6 weeks, milk administration may continue for an additional 6 weeks.
Outcomes
Primary Outcome Measures
Loose/Unformed/Liquid Stools or Abdominal Cramping
Episodes or number of days of loose/unformed/liquid stools or abdominal cramping will be reported.
Norovirus
Stool samples will be tested for the presence of norovirus.
Secondary Outcome Measures
Full Information
NCT ID
NCT02371538
First Posted
February 19, 2015
Last Updated
August 18, 2020
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Mothers' Milk Bank Northeast
1. Study Identification
Unique Protocol Identification Number
NCT02371538
Brief Title
Human Breastmilk in Young Children With Norovirus Infection of the Gut
Official Title
A Pilot Study of Enteral Donor Human Milk in Young Children With Norovirus Infection of the Gut
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual.
Study Start Date
October 2014 (undefined)
Primary Completion Date
July 2, 2016 (Actual)
Study Completion Date
July 2, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Mothers' Milk Bank Northeast
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Human Breast milk in young children with Norovirus Infection
Detailed Description
The investigators hypothesize that children with clinically significant norovirus infection of the gut who receive enteral human milk will more successfully clear the virus or experience improved symptoms compared to children not receiving human milk.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Norovirus Infections
Keywords
stem cell transplant, human breastmilk
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Donor Breastmilk
Arm Type
Experimental
Arm Description
Donated human milk is subjected to pasteurization prior to use. Milk consumption is to be overseen by a Registered Dietician. Oral or enteral milk feeding will begin at 180 ml/day and will be advanced as quickly as tolerated to a goal of 360 ml/day for 6 weeks. If symptoms and stool tests for norovirus do not improve after 6 weeks, milk administration may continue for an additional 6 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Donor Breastmilk
Intervention Description
Donor breastmilk will be obtained from the Mother's Milk Bank of New England.
Primary Outcome Measure Information:
Title
Loose/Unformed/Liquid Stools or Abdominal Cramping
Description
Episodes or number of days of loose/unformed/liquid stools or abdominal cramping will be reported.
Time Frame
Up to 12 weeks
Title
Norovirus
Description
Stool samples will be tested for the presence of norovirus.
Time Frame
Up to 12 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children with at least two stool samples taken at least 7 days apart that are positive for norovirus
Child has an underlying disease or has received immunosuppressive medication or chemotherapy such that clearance of norovirus is expected to be impaired.
Exclusion Criteria:
The presence of other pathogens causing diarrhea that have specific treatments does not preclude enrollment. However, specific treatment should be offered in addition to human milk.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javier El-Bietar, MD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Human Breastmilk in Young Children With Norovirus Infection of the Gut
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