Comparing single versus repeat nasal microbiota transplants in newborns

Comparing Single Versus Repeat Parent-to-Child Nasal Microbiome Transplant on Seeding, Engraftment, and Diversity of the Neonatal Nasal Microbiome

This study is testing if giving newborns a nasal transplant of helpful bacteria from their parents can improve their health, comparing the effects of one transplant versus multiple transplants.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 175 (estimated)
• Ages: 0 Years to 60 Years
• Sex: All
• Sponsor: Johns Hopkins University (other)
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT06283355 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of a nasal microbiota transplant (NMT) from parents to their neonates to enhance the diversity of the neonatal microbiome. Conducted in the Johns Hopkins Neonatal Intensive Care Unit, eligible neonates will receive either a single or repeat NMT after parental consent and screening. The primary focus is to determine if the transplant can successfully seed and engraft beneficial organisms into the neonate's microbiome, potentially improving their health outcomes.

Who should consider this trial

Good fit: Ideal candidates include neonates admitted to the NICU who are at least 25 weeks gestation and have parents not colonized with Staphylococcus aureus.

Not a fit: Patients who have a history of Staphylococcus aureus colonization or those with immunodeficiencies may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the neonatal microbiome diversity, potentially reducing the risk of infections and promoting better health in newborns.

How similar studies have performed: While the approach of nasal microbiota transplant is relatively novel, similar studies have shown promise in enhancing microbiome diversity in other populations.

Eligibility criteria

Inclusion Criteria:

Neonate:

1. Neonate has anticipated NICU length of stay \> 7 days
2. Neonate ≥25 weeks gestation
3. At least one parent/adult provider not colonized with S. aureus (as determined by baseline screening)
4. Neonate is not colonized with S. aureus on baseline screening

Parent/Adult provider:

1\. Parent/Adult provider is able to provide informed consent

Exclusion Criteria:

Neonate:

1. Neonate has had a prior clinical or surveillance culture grow S. aureus
2. Neonate is a ward of the State
3. Neonate with antenatal suspicion for immunodeficiency (e.g. sibling with known immunodeficiency, genetic syndrome with known associated immunodeficiency)
4. Neonate cannot have nasal swabs collected (due to anatomic or other clinical intervention, including nasal packing)

Parent/Adult provider:

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

Where this trial is running

Baltimore, Maryland

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

Study contacts

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

Conditions: Staphylococcus Aureus, Microbial Colonization, Neonatal Infection, microbiome