RecruitingPhase 1NCT06805994
Administering NMT to Reestablish Infant Nasal Microbiome Diversity Following Intranasal Mupirocin Treatment
Parent-to-Child Nasal Microbiota Transplant to Reestablish Nasal Microbiome Diversity After Intranasal Mupirocin Treatment of Children With Staphylococcus Aureus Nasal Colonization
Sponsor
Johns Hopkins University
Enrollment
175 participants
Start Date
Aug 27, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
This protocol aims to evaluate how NMT affects pediatric nasal microbiome diversity following intranasal mupirocin treatment
Eligibility
Min Age: 0 YearsMax Age: 60 Years
Inclusion Criteria8
- Child:
- Child has had a prior nasal surveillance culture grow S. aurues
- Child is <18 years of age
- Child completed treatment with intranasal mupirocin for S. aureus nasal colonization as part of routine clinical care two or more days before the planned transplant
- Child has anticipated hospital length of stay >3 days after completing intranasal mupirocin treatment
- Infant >25 weeks gestation unless >2 months chronological age
- Donor is able to provide informed consent
- Donor has a relationship with the child outside of the hospital setting (i.e., not an ICU caregiver)
Exclusion Criteria14
- Child is a ward of the State
- Child with a diagnosis of immunodeficiency or antenatal suspicion for immunodeficiency (e.g., sibling with known immunodeficiency, genetic syndrome with known associated immunodeficiency)
- Child cannot have nasal swabs collected (due to anatomic or other clinical intervention, including nasal packing)
- Donor:
- Donor had positive COVID-19 test in prior 21 days
- Donor with signs or symptoms of respiratory illness (e.g. runny nose, congestion, fever, cough)
- Donor has been in close contact with someone in the last 7 days who had a respiratory viral infection (e.g., cold, flu)
- Donor tests positive on baseline screening test for S. aureus nasal colonization.
- Donor tests positive on baseline screening test for a respiratory pathogen.
- Donor is not able to provide written informed consent
- Donor is not able to be present at the bedside at the time of intervention.
- Donor has history of chronic sinusitis, cystic fibrosis, or an infection with a multi-drug resistant organism.
- Inability or unwillingness to complete the Donor questionnaire or a positive response to any question on the Donor questionnaire.
- Donor has smoked within the last month
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Interventions
BIOLOGICALNasal Microbiota Transplant (NMT)
nasal microbiota transplant
BIOLOGICALPlacebo
Placebo sterile swab
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06805994
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