Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05695196

Feasibility and Safety Study of Parent-to-Child Nasal Microbiota Transplant

This feasibility and safety pilot study looks to determine whether transferring a parents healthy, diverse nasal microbiota to the participant's infant(s) will create a healthy, diverse neonatal nasal microbiome.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

Up to 60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

About this study

The parent-to-child NMT study is a pilot study to test the feasibility of a parent-to-child nasal microbiome transplant. The investigators will test parent-to-neonate nasal microbiome transplantation as an intervention to reduce S. aureus acquisition in neonates. Neonates admitted to the Johns Hopkins Hospital 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 a nasal microbiome transplant. This pilot study looks to determine whether transferring a parents healthy, diverse nasal microbiota to the infant(s) will create a healthy, diverse neonatal nasal microbiome. The investigators are planning an upcoming randomized controlled trial of this intervention and hope to establish feasibility during this pilot study.

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 saline

Primary outcomes

  1. Neonatal nasal microbiome diversity after intervention

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

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

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

Feasibility and Safety Study of Parent-to-Child Nasal Microbiota Transplant to Promote Colonization Resistance to Staphylococcus Aureus

Acronym: ParentsTREAT

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jan 23, 2023
Registry last updated
Dec 11, 2025

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.

Published trials that share one or more normalized conditions with this study.