Human Breastmilk in Young Children With Norovirus Infection of the Gut

Cincinnati Children's Hospital Medical Center

Status: Terminated

Conditions: Norovirus Infections

Treatments: Dietary Supplement: Donor Breastmilk

Study type: Interventional

Funder types: Other

Identifiers

NCT02371538

2014-3363

Details and patient eligibility

About

Human Breast milk in young children with Norovirus Infection

Full 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.

Enrollment: 4 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Donor Breastmilk

Experimental group

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.

Treatment:

Dietary Supplement: Donor Breastmilk