Administering NMT to Reestablish Infant Nasal Microbiome Diversity Following Intranasal Mupirocin Treatment

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age0-60
SponsorJohns Hopkins University

About this trial

This protocol aims to evaluate how NMT affects pediatric nasal microbiome diversity following intranasal mupirocin treatment

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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 is able to provide informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nasal Microbiota Transplant (NMT)

    Biological/Vaccine

    nasal microbiota transplant

  • Placebo

    Biological/Vaccine

    Placebo sterile swab

Treatment groups

175 Participants
are divided into 3 treatment groups
Group A: Single NMTExperimental treatment 1 intervention
Group B: Repeat NMTExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pediatric nasal microbiome diversity after parent-to-child NMT.

This outcome will be determined by analysis of periodic surveillance swabs collected after intervention.

Time frame
Day 2, 4, 7, 10, 14 days post-intervention

Secondary outcomes

Other outcomes

Sponsors and contacts

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