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

Last updated: June 5, 2025
Sponsor: Johns Hopkins University
Overall Status: Active - Not Recruiting

Phase

1

Condition

Staphylococcal Infections

Treatment

nasal microbiota transplant (NMT)

Placebo

Clinical Study ID

NCT05695196
IRB00361302
  • Ages < 60
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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 bybaseline 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

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 knownimmunodeficiency, genetic syndrome with known associated immunodeficiency)

  4. Neonate cannot have nasal swabs collected (due to anatomic or other clinicalintervention, 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. runnynose, congestion, fever, cough)

  3. Parent/adult provider has been in close contact with someone in the last 7 days whohad a respiratory viral infection, like the cold or the flu?

  4. Parent/adult provider tests positive on baseline screening test for S. aureus nasalcolonization.

  5. Parent/adult provider tests positive on baseline screening test for a respiratorypathogen.

  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 ofintervention.

  8. Parent/adult provider has history of chronic sinusitis, cystic fibrosis, or aninfection with a multi-drug resistant organism.

  9. Inability or unwillingness to complete the Donor questionnaire or a positiveresponse to any question on the Donor questionnaire

Study Design

Total Participants: 34
Treatment Group(s): 2
Primary Treatment: nasal microbiota transplant (NMT)
Phase: 1
Study Start date:
October 25, 2023
Estimated Completion Date:
December 01, 2025

Study Description

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.

Connect with a study center

  • Johns Hopkins University

    Baltimore, Maryland 21287
    United States

    Site Not Available

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