Human Breastmilk in Young Children With Norovirus Infection of the Gut

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-07-02

Brief Summary

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Human Breast milk in young children with Norovirus Infection

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Detailed Description

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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.

Conditions

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Norovirus Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Donor Breastmilk

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.

Group Type EXPERIMENTAL

Donor Breastmilk

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Donor Breastmilk

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No