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

NCT06283355 | Recruiting Phase 1 FDA Drug

• 1 other identifier: IRB00433691
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Staphylococcus Aureus; Microbial Colonization; Neonatal Infection

Keywords

microbiome

Outcome Measures

Primary Outcomes (1)

• Neonatal nasal microbiome diversity after intervention

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

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

Study Arms (3)

Single NMT

EXPERIMENTAL

Swab parent nares then insert swab directly into neonate nares once.

Biological: Nasal Microbiota Transplant (NMT)

Repeat NMT

EXPERIMENTAL

Swab parents nares then insert swab directly into neonate nares multiple times.

Biological: Nasal Microbiota Transplant (NMT)

Placebo

PLACEBO COMPARATOR

Insert a sterile swab into neonate nares.

Biological: Placebo

Interventions

Nasal Microbiota Transplant (NMT) BIOLOGICAL

nasal microbiota transplant

Repeat NMT; Single NMT

Placebo BIOLOGICAL

Placebo sterile swab

Placebo

Eligibility Criteria

• Age: 0 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Neonate:
• Neonate has anticipated NICU length of stay \> 7 days
• Neonate ≥25 weeks gestation
• At least one parent/adult provider not colonized with S. aureus (as determined by baseline screening)
• Neonate is not colonized with S. aureus on baseline screening
• Parent/Adult provider:
• \. Parent/Adult provider is able to provide informed consent

You may not qualify if:

• Neonate:
• Neonate has had a prior clinical or surveillance culture grow S. aureus
• Neonate is a ward of the State
• Neonate with antenatal suspicion for immunodeficiency (e.g. sibling with known immunodeficiency, genetic syndrome with known associated immunodeficiency)
• Neonate cannot have nasal swabs collected (due to anatomic or other clinical intervention, including nasal packing)
• Parent/Adult provider:
• Parent/adult provider had positive COVID-19 test in prior 21 days
• Parent/adult provider with signs or symptoms of respiratory illness (e.g. runny nose, congestion, fever, cough)
• Parent/adult provider has been in close contact with someone in the last 7 days who had a respiratory viral infection, like the cold or the flu?
• Parent/adult provider tests positive on baseline screening test for S. aureus nasal colonization.
• Parent/adult provider tests positive on baseline screening test for a respiratory pathogen.
• Parent/adult provider is not able to provide written informed consent
• Parent/adult provider is not able to be present at the bedside at the time of intervention.
• Parent/adult provider 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Staphylococcal Infections; Communicable Diseases

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Aaron Milstone, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danielle Koontz

CONTACT

443-287-9040; dkoontz1@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: February 28, 2024
• Study Start: September 3, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)