Human Breastmilk in Young Children With Norovirus Infection of the Gut

Not Applicable

Terminated

• Conditions: Norovirus Infections
• Interventions: Dietary Supplement: Donor Breastmilk

• Registration Number: NCT02371538
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

Human Breast milk in young children with Norovirus Infection

Detailed 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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-02-19
• Study First Submitted QC: 2015-02-19
• Study First Posted: 2015-02-25
• Primary Completion: 2016-07-02
• Study Completion: 2016-07-02
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-18
• Last Update Posted: 2020-08-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Donor Breastmilk	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.

Primary Outcome Measures

Name	Time	Method
Norovirus	Up to 12 weeks	Stool samples will be tested for the presence of norovirus.
Loose/Unformed/Liquid Stools or Abdominal Cramping	Up to 12 weeks	Episodes or number of days of loose/unformed/liquid stools or abdominal cramping will be reported.

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States