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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT06805994
Phase
PHASE1
Status
Recruiting
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Conditions

  • Microbial Colonization
  • Microbial Transplant
  • Pediatric Infection
  • S. Aureus Colonization
  • Staphylococcal Aureus Infection

Eligibility Criteria

Sex
ALL
Age
0 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Nasal Microbiota Transplant (NMT) — BIOLOGICAL
    nasal microbiota transplant
  • Placebo — BIOLOGICAL
    Placebo sterile swab

Study Details

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

Key Dates

Start date
Aug 27, 2025
Status verified
Aug 2025
Primary completion
Sep 1, 2027
Completion
Jan 1, 2028

Study Design

Enrollment
175 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Single NMT
    Swab parent nares then insert swab directly into child nares once.
  • Experimental: Repeat NMT
    Swab parents nares then insert swab directly into child nares multiple times.
  • Placebo Comparator: Placebo
    Insert a sterile swab into child nares.

Primary Outcome Measure

Pediatric nasal microbiome diversity after parent-to-child NMT. [ Time Frame: Day 2, 4, 7, 10, 14 days post-intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins UniversityBaltimoreMaryland21287
Danielle Koontz, Research Manager
[email protected]
443-287-9040
Aaron M Milstone, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Johns Hopkins University· Baltimore, MD

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