Recruiting
Phase 1

NMT with Mupirocin

Sponsor:

Johns Hopkins University

Code:

NCT06805994

Conditions

Staphylococcal Aureus Infection

Microbial Colonization

Pediatric Infection

S. Aureus Colonization

Microbial Transplant

Eligibility Criteria

Sex: All

Age: 0 - 60

Healthy Volunteers: Accepted

Interventions

Nasal Microbiota Transplant (NMT)

Placebo

Study Details

Brief summary:

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

Conditions

Staphylococcal Aureus Infection

Microbial Colonization

Pediatric Infection

S. Aureus Colonization

Microbial Transplant

Study ID

NCT06805994

Start date

Aug 27, 2025

Status verified date

Aug, 2026

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 60

Healthy Volunteers: Accepted

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 Design

Enrollment

175 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Single NMT

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

experimental: Repeat NMT

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

placebo comparator: Placebo

Insert a sterile swab into child nares.

Interventions

Nasal Microbiota Transplant (NMT)

nasal microbiota transplant

Placebo

Placebo sterile swab

Primary outcome measure

  • Pediatric nasal microbiome diversity after parent-to-child NMT. [ Time Frame: Day 2, 4, 7, 10, 14 days post-intervention ]

Central Contacts and Locations

Central contacts

Danielle Koontz, Research Manager

4432879040dkoontz1@jhmi.edu

Slade Decker, Senior Research Coordinator

4109550405sdecker9@jhmi.edu

Locations

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Danielle Koontz, Research Manager

443-287-9040dkoontz1@jhmi.edu

Principal Investigator:

Aaron M Milstone, MD

More Information

Sponsor

Johns Hopkins University

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

  • microbiome
  • s. aureus
  • staph

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-08-10.