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NCT Number: NCT06805994

Administering NMT to Reestablish Infant Nasal Microbiome Diversity Following Intranasal Mupirocin Treatment

This protocol aims to evaluate how NMT affects pediatric nasal microbiome diversity following intranasal mupirocin treatment

Recruiting

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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 M Milstone, MD

PRINCIPAL_INVESTIGATOR

Danielle Koontz, Research Manager

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 following nasal decolonization for S. aureus. Infants 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 infants, eligible infants will undergo an NMT.

Who can participate

Healthy volunteers accepted: Yes

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

Child:

Inclusion criteria

  • Child has had a prior nasal surveillance culture grow S. aurues
  • Child is <18 years of age
  • Child completed treatment with intranasal mupirocin for S. aureus nasal colonization as part of routine clinical care two or more days before the planned transplant
  • Child has anticipated hospital length of stay >3 days after completing intranasal mupirocin treatment
  • Infant >25 weeks gestation unless >2 months chronological age

Exclusion criteria

  • Child is a ward of the State
  • Child with a diagnosis of immunodeficiency or antenatal suspicion for immunodeficiency (e.g., sibling with known immunodeficiency, genetic syndrome with known associated immunodeficiency)
  • Child cannot have nasal swabs collected (due to anatomic or other clinical intervention, including nasal packing)

Donor:

Inclusion criteria

  • Donor is able to provide informed consent
  • Donor has a relationship with the child outside of the hospital setting (i.e., not an ICU caregiver)

Exclusion criteria

  • Donor had positive COVID-19 test in prior 21 days
  • Donor with signs or symptoms of respiratory illness (e.g. runny nose, congestion, fever, cough)
  • Donor has been in close contact with someone in the last 7 days who had a respiratory viral infection (e.g., cold, flu)
  • Donor tests positive on baseline screening test for S. aureus nasal colonization.
  • Donor tests positive on baseline screening test for a respiratory pathogen.
  • Donor is not able to provide written informed consent
  • Donor is not able to be present at the bedside at the time of intervention.
  • Donor 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.
  • Donor has smoked within the last month

Treatment and study plan

Nasal Microbiota Transplant (NMT)

Biological

nasal microbiota transplant

Placebo

Biological

Placebo sterile swab

Primary outcomes

  1. Pediatric nasal microbiome diversity after parent-to-child NMT.

    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, Research Manager

CONTACT

[email protected]

4432879040

Slade Decker, Senior Research Coordinator

CONTACT

[email protected]

4109550405

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

Parent-to-Child Nasal Microbiota Transplant to Reestablish Nasal Microbiome Diversity After Intranasal Mupirocin Treatment of Children With Staphylococcus Aureus Nasal Colonization

Acronym: NMT Protocol 3

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Feb 3, 2025
Registry last updated
Sep 4, 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.

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