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

NCT ID: NCT06283355

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 175 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-03
• Study Completion Date: 2026-12-31

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.

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.

Conditions

Staphylococcus Aureus; Microbial Colonization; Neonatal Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Single NMT

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

Group Type: EXPERIMENTAL

Nasal Microbiota Transplant (NMT)

Intervention Type: BIOLOGICAL

nasal microbiota transplant

Repeat NMT

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

Group Type: EXPERIMENTAL

Nasal Microbiota Transplant (NMT)

Intervention Type: BIOLOGICAL

nasal microbiota transplant

Placebo

Insert a sterile swab into neonate nares.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Placebo sterile swab

Interventions

Nasal Microbiota Transplant (NMT)

nasal microbiota transplant

Intervention Type: BIOLOGICAL

Placebo

Placebo sterile swab

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aaron Milstone, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Danielle Koontz

Role: CONTACT

dkoontz1@jhmi.edu

443-287-9040

Facility Contacts

Danielle Koontz

Role: primary

dkoontz1@jhmi.edu

443-287-9040

Other Identifiers

IRB00433691

Identifier Type: -

Identifier Source: org_study_id