Human Breastmilk in Young Children With Norovirus Infection of the Gut

A Pilot Study of Enteral Donor Human Milk in Young Children With Norovirus Infection of the Gut

Human Breast milk in young children with Norovirus Infection

Study Overview

• Status: Terminated
• Conditions: Norovirus Infections
• Intervention / Treatment: Dietary supplement: Donor Breastmilk

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 Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children'S Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: 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.

Dietary supplement: Donor Breastmilk; Donor breastmilk will be obtained from the Mother's Milk Bank of New England.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: Mothers' Milk Bank Northeast
• Investigators: Principal Investigator: Javier El-Bietar, MD, Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (ACTUAL): July 2, 2016
• Study Completion (ACTUAL): July 2, 2016

Study Registration Dates

• First Submitted: February 19, 2015
• First Submitted That Met QC Criteria: February 19, 2015
• First Posted (ESTIMATE): February 25, 2015

Study Record Updates

• Last Update Posted (ACTUAL): August 20, 2020
• Last Update Submitted That Met QC Criteria: August 18, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: stem cell transplant; human breastmilk
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Disease Attributes; Infections; Communicable Diseases; Caliciviridae Infections
• Other Study ID Numbers: 2014-3363

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No