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

Comparing Single Versus Repeat Parent-to-Child Nasal Microbiome Transplant on Seeding, Engraftment, and Diversity of the Neonatal Nasal Microbiome

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.

Study Overview

• Status: Recruiting
• Conditions: Staphylococcus Aureus; Microbial Colonization; Neonatal Infection
• Intervention / Treatment: Biological: Nasal Microbiota Transplant (NMT); Biological: Placebo

Detailed Description

This parent-to-child NMT study will test the effect of an anterior nares, or nasal, microbiota transplant (NMT) on seeding, engraftment, and diversity of the neonatal microbiome. Neonates admitted to the Johns Hopkins Neonatal Intensive Care Unit (NICU) will be screened and parents will be approached for enrollment in the study. After consent and baseline screening of parents and neonates, eligible neonates will undergo an NMT.

• Study Type: Interventional
• Enrollment (Estimated): 175
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Danielle Koontz; Phone Number: 443-287-9040; Email: dkoontz1@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins University
      • Principal Investigator: Aaron Milstone
      • Contact: Danielle Koontz; Phone Number: 443-287-9040; Email: dkoontz1@jhmi.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Neonate:

1. Neonate has anticipated NICU length of stay > 7 days
2. Neonate ≥25 weeks gestation
3. At least one parent/adult provider not colonized with S. aureus (as determined by baseline screening)
4. Neonate is not colonized with S. aureus on baseline screening

Parent/Adult provider:

1. Parent/Adult provider is able to provide informed consent

Exclusion Criteria:

Neonate:

1. Neonate has had a prior clinical or surveillance culture grow S. aureus
2. Neonate is a ward of the State
3. Neonate with antenatal suspicion for immunodeficiency (e.g. sibling with known immunodeficiency, genetic syndrome with known associated immunodeficiency)
4. Neonate cannot have nasal swabs collected (due to anatomic or other clinical intervention, including nasal packing)

Parent/Adult provider:

1. Parent/adult provider had positive COVID-19 test in prior 21 days
2. Parent/adult provider with signs or symptoms of respiratory illness (e.g. runny nose, congestion, fever, cough)
3. 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?
4. Parent/adult provider tests positive on baseline screening test for S. aureus nasal colonization.
5. Parent/adult provider tests positive on baseline screening test for a respiratory pathogen.
6. Parent/adult provider is not able to provide written informed consent
7. Parent/adult provider is not able to be present at the bedside at the time of intervention.
8. Parent/adult provider has history of chronic sinusitis, cystic fibrosis, or an infection with a multi-drug resistant organism.
9. Inability or unwillingness to complete the Donor questionnaire or a positive response to any question on the Donor questionnaire

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single NMT; Swab parent nares then insert swab directly into neonate nares once.	Biological: Nasal Microbiota Transplant (NMT); nasal microbiota transplant
Experimental: Repeat NMT; Swab parents nares then insert swab directly into neonate nares multiple times.	Biological: Nasal Microbiota Transplant (NMT); nasal microbiota transplant
Placebo Comparator: Placebo; Insert a sterile swab into neonate nares.	Biological: Placebo; Placebo sterile swab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Aaron Milstone, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Estimated): September 11, 2025
• Last Update Submitted That Met QC Criteria: September 10, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: microbiome
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Pathological Conditions, Signs and Symptoms; Staphylococcal Infections; Communicable Diseases; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: IRB00433691

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No