Actively Recruiting
Parent-to-Child Nasal Microbiota Transplant to Reestablish Nasal Microbiome Diversity After Intranasal Mupirocin Treatment of Children With Staphylococcus Aureus Nasal Colonization
Led by Johns Hopkins University · Updated on 2025-09-04
175
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate how a nasal microbiota transplant (NMT) from parents affects the diversity of the nasal microbiome in infants after they have been treated with intranasal mupirocin to clear Staphylococcus aureus colonization. The study focuses on infants in a neonatal intensive care unit who have undergone nasal decolonization and seeks to understand the impact of this transplant on the infant's nasal bacterial community. Participants will be randomly assigned to one of three groups: a single NMT where a swab from the parent's nose is inserted once into the child's nose, a repeat NMT with multiple swab insertions, or a placebo group where a sterile swab is inserted without microbiota transfer. The interventions take place after baseline screening, and the study is designed as a phase 1, randomized trial without masking. During the study, researchers will monitor pediatric nasal microbiome diversity at several time points after the intervention—specifically on days 2, 4, 7, 10, and 14. Assessments include nasal swabs and microbiome analyses to evaluate how well the transplant affects bacterial diversity. Infant participants are expected to remain hospitalized for at least three days post-treatment to allow monitoring. The study duration extends to 2028 and involves healthy volunteers aged from birth up to 5 years old.
CONDITIONS
Brief Title
Administering NMT to Reestablish Infant Nasal Microbiome Diversity Following Intranasal Mupirocin Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Child has had a prior nasal surveillance culture grow Staphylococcus aureus
- Child is younger than 18 years of age
- Child completed treatment with intranasal mupirocin for S. aureus nasal colonization at least two days before planned transplant
- Child has anticipated hospital stay longer than 3 days after completing mupirocin treatment
- Infant is older than 25 weeks gestation unless older than 2 months chronological age
- Donor is able to provide informed consent
- Donor has a relationship with the child outside the hospital (not an ICU caregiver)
You will not qualify if you...
- Child is a ward of the State
- Child has diagnosed or suspected immunodeficiency
- Child cannot have nasal swabs collected due to clinical reasons
- Donor had positive COVID-19 test in prior 21 days
- Donor has respiratory illness symptoms
- Donor had close contact with respiratory viral infection in last 7 days
- Donor tests positive for S. aureus nasal colonization or respiratory pathogens
- Donor cannot provide written informed consent or be present at intervention
- Donor has history of chronic sinusitis, cystic fibrosis, or multi-drug resistant infection
- Donor is unable or unwilling to complete donor questionnaire or smoked in last month
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single or multiple treatments depending on assigned group
Participants receive a nasal microbiota transplant (NMT) or placebo swab to reestablish nasal microbiome diversity following mupirocin treatment.
1 to multiple visits depending on treatment arm
Duration - 14 days post-intervention
Participants are monitored to assess nasal microbiome diversity after the intervention.
Visits on Days 2, 4, 7, 10, and 14 after treatment
Trial Site Locations
Total: 1 location
1
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
D
Danielle Koontz, Research Manager
S
Slade Decker, Senior Research Coordinator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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