Human Breastmilk in Young Children With Norovirus Infection of the Gut

Norovirus Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02371538
• Other study ID #: 2014-3363
• Status: Terminated
• Phase: N/A
• Start date: October 2014
• Est. completion date: July 2, 2016

Study information

• Verified date: August 2020
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Human Breast milk in young children with Norovirus Infection

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: July 2, 2016
• Est. primary completion date: July 2, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Norovirus Infections

Intervention

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

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Mothers' Milk Bank Northeast

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Norovirus	Stool samples will be tested for the presence of norovirus.	Up to 12 weeks