Nasal microbiota transplant to restore infant nasal microbiome after intranasal mupirocin

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

This trial will try a parent-to-child nasal microbiota transplant to see if it restores nasal microbial diversity in newborns after intranasal mupirocin treatment for S. aureus.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 175 (estimated)
• Ages: 0 Years to 60 Years
• Sex: All
• Sponsor: Johns Hopkins University (Academic / other)
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT06805994 on ClinicalTrials.gov

What this trial studies

This phase 1, parent-to-child nasal microbiota transplant (NMT) protocol enrolls infants in the Johns Hopkins NICU who have completed intranasal mupirocin for S. aureus decolonization. After consent and baseline screening of parents and infants, eligible infants receive an anterior nares NMT derived from a screened parent donor or a placebo. Investigators will follow the infants to measure seeding, engraftment, and changes in nasal microbiome diversity after the transplant. Safety monitoring and nasal swab sampling are included as part of routine follow-up.

Who should consider this trial

Good fit: Ideal candidates are infants admitted to the Johns Hopkins NICU under 18 years who had prior S. aureus nasal colonization, completed intranasal mupirocin at least two days earlier, are >25 weeks gestation (unless >2 months chronological age), and have an available parent donor who can consent.

Not a fit: Infants with known or suspected immunodeficiency, those who cannot undergo nasal swabbing or transplantation, wards of the state, or infants without an eligible consenting parent donor are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, NMT could help reestablish a healthy nasal microbiome in infants and reduce S. aureus recolonization and related infections.

How similar studies have performed: While gut microbiota transplants have shown promise in other settings, parent-to-child nasal microbiota transplant for reestablishing the neonatal nasal microbiome is novel with limited prior clinical data.

Eligibility criteria

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

Where this trial is running

Baltimore, Maryland

• Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Aaron M Milstone, MD — Johns Hopkins University
• Study coordinator: Danielle Koontz, Research Manager

Conditions Staphylococcal Aureus Infection; Microbial Colonization; Pediatric Infection; S. Aureus Colonization; Microbial Transplant; microbiome; s. aureus; staph