Human Breastmilk in Young Children With Norovirus Infection of the Gut

Children's Hospital Medical Center, Cincinnati4 enrolled

Overview

Human Breast milk in young children with Norovirus Infection

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Norovirus Infections

Interventions

Donor BreastmilkDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

Loose/Unformed/Liquid Stools or Abdominal Cramping

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

Time frame: Up to 12 weeks

Norovirus

Stool samples will be tested for the presence of norovirus.

Time frame: Up to 12 weeks

Data from ClinicalTrials.gov

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