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

NCT ID: NCT06805994

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 175 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-27
• Study Completion Date: 2028-01-01

Brief Summary

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

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.

Conditions

Staphylococcal Aureus Infection; Microbial Colonization; Pediatric Infection; S. Aureus Colonization; Microbial Transplant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Single NMT

Swab parent nares then insert swab directly into child nares once.

Group Type: EXPERIMENTAL

Nasal Microbiota Transplant (NMT)

Intervention Type: BIOLOGICAL

nasal microbiota transplant

Repeat NMT

Swab parents nares then insert swab directly into child nares multiple times.

Group Type: EXPERIMENTAL

Nasal Microbiota Transplant (NMT)

Intervention Type: BIOLOGICAL

nasal microbiota transplant

Placebo

Insert a sterile swab into child nares.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Placebo sterile swab

Interventions

Nasal Microbiota Transplant (NMT)

nasal microbiota transplant

Intervention Type: BIOLOGICAL

Placebo

Placebo sterile swab

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

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. 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:

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

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aaron M Milstone, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Danielle Koontz, Research Manager

Role: CONTACT

dkoontz1@jhmi.edu

4432879040

Slade Decker, Senior Research Coordinator

Role: CONTACT

sdecker9@jhmi.edu

4109550405

Facility Contacts

Danielle Koontz, Research Manager

Role: primary

dkoontz1@jhmi.edu

443-287-9040

Other Identifiers

IRB00480834

Identifier Type: -

Identifier Source: org_study_id