Administering NMT to Reestablish Infant Nasal Microbiome Diversity Following Intranasal Mupirocin Treatment (NMT Protocol 3)

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

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

Study Overview

• Status: Recruiting
• Conditions: Microbial Colonization; Staphylococcal Aureus Infection; Pediatric Infection; S. Aureus Colonization; Microbial Transplant
• Intervention / Treatment: Biological: Nasal Microbiota Transplant (NMT); Biological: Placebo

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 175
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Danielle Koontz, Research Manager; Phone Number: 4432879040; Email: dkoontz1@jhmi.edu
• Study Contact Backup: Name: Slade Decker, Senior Research Coordinator; Phone Number: 4109550405; Email: sdecker9@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins University
      • Contact: Danielle Koontz, Research Manager; Phone Number: 443-287-9040; Email: dkoontz1@jhmi.edu
      • Principal Investigator: Aaron M Milstone, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Child:

Inclusion criteria

1. Child has had a prior nasal surveillance culture grow S. aurues
2. Child is <18 years of age
3. 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
4. Child has anticipated hospital length of stay >3 days after completing intranasal mupirocin treatment
5. Infant >25 weeks gestation unless >2 months chronological age

Exclusion criteria

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

Donor:

Inclusion criteria

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

Exclusion criteria

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single NMT; Swab parent nares then insert swab directly into child nares once.	Biological: Nasal Microbiota Transplant (NMT); nasal microbiota transplant
Experimental: Repeat NMT; Swab parents nares then insert swab directly into child nares multiple times.	Biological: Nasal Microbiota Transplant (NMT); nasal microbiota transplant
Placebo Comparator: Placebo; Insert a sterile swab into child nares.	Biological: Placebo; Placebo sterile swab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pediatric nasal microbiome diversity after parent-to-child NMT.	This outcome will be determined by analysis of periodic surveillance swabs collected after intervention.	Day 2, 4, 7, 10, 14 days post-intervention

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Aaron M Milstone, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: January 28, 2025
• First Submitted That Met QC Criteria: January 28, 2025
• First Posted (Actual): February 3, 2025

Study Record Updates

• Last Update Posted (Estimated): September 4, 2025
• Last Update Submitted That Met QC Criteria: August 27, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: microbiome; staph; s. aureus
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Pathological Conditions, Signs and Symptoms; Staphylococcal Infections; Communicable Diseases; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: IRB00480834

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No