Norovirus Infections
Conditions
Keywords
stem cell transplant, human breastmilk
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.
Interventions
DIETARY_SUPPLEMENTDonor Breastmilk
Donor breastmilk will be obtained from the Mother's Milk Bank of New England.
Sponsors
Mothers' Milk Bank Northeast
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Norovirus | Up to 12 weeks | Stool samples will be tested for the presence of norovirus. |
Countries
United States
Outcome results
None listed