Nasal microbiota transplant to restore infant nasal microbiome after intranasal mupirocin

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: dkoontz1@jhmi.edu
• Phone: 4432879040

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.