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NCT Number: NCT06283355

Comparing Single Versus Repeat NMT on the 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.

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Key information

Age range

0 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location status: Recruiting

Location contact

Aaron Milstone

PRINCIPAL_INVESTIGATOR

Danielle Koontz

CONTACT

[email protected]

443-287-9040

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Nasal Microbiota Transplant (NMT)

Biological

nasal microbiota transplant

Placebo

Biological

Placebo sterile swab

Primary outcomes

  1. Neonatal nasal microbiome diversity after intervention

    Time frame: Day 2, 4, 7, 10, 14 days post-intervention

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

Study contacts

Contact information is provided by the study sponsor or research team.

Danielle Koontz

CONTACT

[email protected]

443-287-9040

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 28, 2024
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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