Comparing Single Versus Repeat NMT on the Diversity of the Neonatal Nasal Microbiome

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT06283355
Phase
PHASE1
Status
Recruiting
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Conditions

  • Microbial Colonization
  • Neonatal Infection
  • Staphylococcus Aureus

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 study aims to determine whether a parent-to-child nasal microbiota transplant (NMT) can seed and engraft parental organisms into the neonatal microbiome and increase the neonatal microbiome diversity.

Key Dates

Start date
Sep 3, 2024
Status verified
Jun 2026
Primary completion
Sep 1, 2026
Completion
Dec 31, 2026

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

Primary Outcome Measure

Neonatal nasal microbiome diversity after intervention [ Time Frame: Day 2, 4, 7, 10, 14 days post-intervention ]

Central Contacts

Locations (1)

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

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Johns Hopkins University· Baltimore, MD

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