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Could a Parent's nose bacteria shield newborns from staph?

NCT ID NCT05695196

Disease control Sponsor: Johns Hopkins University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early study tests whether transferring a parent's healthy nasal bacteria to their newborn can help prevent staph infections. Researchers will give the baby a nasal spray containing the parent's bacteria or a placebo, then monitor the baby's nose bacteria and safety. The study involves 34 infants in the NICU and aims to see if this approach is feasible and safe.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nasal microbiota transplant (NMT)
What this could lead to
If it works, this could point toward a simple way to protect vulnerable newborns from dangerous staph infections.
What could go wrong
This is a very early Phase 1 trial with only 34 participants, so it may not show clear benefit or could have unexpected side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

34 people

The number who actually took part.

Started

Oct 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

infectious disease staphylococcal infection staphylococcus aureus infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Microbial colonization Neonatal infection Staphylococcus aureus

Contacts and locations

Locations

  • Johns Hopkins University

    Baltimore, Maryland, 21287, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.