NCT02371538

Brief Summary

Human Breast milk in young children with Norovirus Infection

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 25, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2016

Completed
Last Updated

August 20, 2020

Status Verified

August 1, 2020

Enrollment Period

1.8 years

First QC Date

February 19, 2015

Last Update Submit

August 18, 2020

Conditions

Norovirus Infections

Keywords

stem cell transplanthuman breastmilk

Outcome Measures

Primary Outcomes (2)

  • Loose/Unformed/Liquid Stools or Abdominal Cramping

    Episodes or number of days of loose/unformed/liquid stools or abdominal cramping will be reported.

    Up to 12 weeks

  • Norovirus

    Stool samples will be tested for the presence of norovirus.

    Up to 12 weeks

Study Arms (1)

Donor Breastmilk

EXPERIMENTAL

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.

Dietary Supplement: Donor Breastmilk

Interventions

Donor BreastmilkDIETARY_SUPPLEMENT

Donor breastmilk will be obtained from the Mother's Milk Bank of New England.

Donor Breastmilk

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Caliciviridae Infections

Condition Hierarchy (Ancestors)

RNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Javier El-Bietar, MD

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2015

First Posted

February 25, 2015

Study Start

October 1, 2014

Primary Completion

July 2, 2016

Study Completion

July 2, 2016

Last Updated

August 20, 2020

Record last verified: 2020-08

Locations

US(1)