Trials Sponsors Conditions Drugs Pricing

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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:

Sponsors & Collaborators

Children's Hospital Medical Center, Cincinnati
Otherlead
Mothers' Milk Bank Northeast
Othercollaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

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

Enrollment

4 participants (actual enrollment reported by the registry).

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 2014

Date type not reported

This date has not been verified as actual or estimated.

Study Stopped

Human Breastmilk in Young Children With Norovirus Infection of the Gut

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

Donor Breastmilk

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

Donor Breastmilk

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations