Staphylococcal Aureus InfectionPhase 1NMT Protocol 3NCT06805994
Administering NMT to Reestablish Infant Nasal Microbiome Diversity Following Intranasal Mupirocin Treatment
A Phase 1 study testing Nasal Microbiota Transplant (NMT) in people with Staphylococcal Aureus Infection and Microbial Colonization, run by Johns Hopkins University at 1 site in United States.
Trial summary
This protocol aims to evaluate how NMT affects pediatric nasal microbiome diversity following intranasal mupirocin treatment Read more about this study
- Who is it for?
- Ages 0 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Staphylococcal Aureus Infection, Microbial Colonization, Pediatric Infection
- What is being tested?
- Nasal Microbiota Transplant (NMT)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2025to 1 Jan 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Child has had a prior nasal surveillance culture grow S. aurues
- Child is <18 years of age
- 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
- Child has anticipated hospital length of stay >3 days after completing intranasal mupirocin treatment
- Infant >25 weeks gestation unless >2 months chronological age
- Donor is able to provide informed consent
- Donor has a relationship with the child outside of the hospital setting (i.e., not an ICU caregiver)
Who cannot join
- Child is a ward of the State
- Child with a diagnosis of immunodeficiency or antenatal suspicion for immunodeficiency (e.g., sibling with known immunodeficiency, genetic syndrome with known associated immunodeficiency)
- Child cannot have nasal swabs collected (due to anatomic or other clinical intervention, including nasal packing)
- Donor:
- Donor had positive COVID-19 test in prior 21 days
- Donor with signs or symptoms of respiratory illness (e.g. runny nose, congestion, fever, cough)
Show all 14Show fewer
- Donor has been in close contact with someone in the last 7 days who had a respiratory viral infection (e.g., cold, flu)
- Donor tests positive on baseline screening test for S. aureus nasal colonization.
- Donor tests positive on baseline screening test for a respiratory pathogen.
- Donor is not able to provide written informed consent
- Donor is not able to be present at the bedside at the time of intervention.
- Donor has history of chronic sinusitis, cystic fibrosis, or an infection with a multi-drug resistant organism.
- Inability or unwillingness to complete the Donor questionnaire or a positive response to any question on the Donor questionnaire.
- Donor has smoked within the last month
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21287
Danielle Koontz, Research Manager, 443-287-9040, dkoontz1@jhmi.edu
Aaron M Milstone, MD
About this study
Official title: Parent-to-Child Nasal Microbiota Transplant to Reestablish Nasal Microbiome Diversity After Intranasal Mupirocin Treatment of Children With Staphylococcus Aureus Nasal Colonization
This protocol aims to evaluate how NMT affects pediatric nasal microbiome diversity following intranasal mupirocin treatment
Read the detailed description
This parent-to-child NMT study will test the effect of an anterior nares, or nasal, microbiota transplant (NMT) on seeding, engraftment, and diversity of the neonatal microbiome following nasal decolonization for S. aureus. Infants admitted to the Johns Hopkins Neonatal Intensive Care Unit (NICU) will be screened and parents will be approached for enrollment in the study. After consent and baseline screening of parents and infants, eligible infants will undergo an NMT.
- Conditions
- Staphylococcal Aureus Infection, Microbial Colonization, Pediatric Infection, S. Aureus Colonization, Microbial Transplant
- Being tested
- Nasal Microbiota Transplant (NMT), Placebo
- Keywords
- microbiome, s. aureus, staph
- Medical subject headings
- Communicable Diseases, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal Microbiota Transplant (NMT)Biological
nasal microbiota transplant
PlaceboBiological
Placebo sterile swab
| Study group | Role | What they receive |
|---|---|---|
| Single NMT | Experimental | Swab parent nares then insert swab directly into child nares once. Receives: Biological: Nasal Microbiota Transplant (NMT) |
| Repeat NMT | Experimental | Swab parents nares then insert swab directly into child nares multiple times. Receives: Biological: Nasal Microbiota Transplant (NMT) |
| Placebo | Placebo comparator | Insert a sterile swab into child nares. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric nasal microbiome diversity after parent-to-child NMT.
This outcome will be determined by analysis of periodic surveillance swabs collected after intervention.
Measured: Day 2, 4, 7, 10, 14 days post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start27 Aug 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcal Aureus InfectionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aaron M Milstone, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06805994
- Sponsor's protocol ID
- IRB00480834
- Acronym
- NMT Protocol 3
- Status last verified
- Aug 2026
- First submitted
- 28 Jan 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent-to-Child Nasal Microbiota Transplant to Reestablish Nasal Microbiome Diversity After Intranasal Mupirocin Treatment of Children With Staphylococcus Aureus Nasal Colonization
- ClinicalTrials.gov ID
- NCT06805994
- Acronym / sponsor ID
- NMT Protocol 3 / IRB00480834
- Conditions
- Staphylococcal Aureus Infection, Microbial Colonization, Pediatric Infection, S. Aureus Colonization, Microbial Transplant
- Keywords
- microbiome, s. aureus, staph
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 27 Aug 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This protocol aims to evaluate how NMT affects pediatric nasal microbiome diversity following intranasal mupirocin treatment
Detailed description
This parent-to-child NMT study will test the effect of an anterior nares, or nasal, microbiota transplant (NMT) on seeding, engraftment, and diversity of the neonatal microbiome following nasal decolonization for S. aureus. Infants admitted to the Johns Hopkins Neonatal Intensive Care Unit (NICU) will be screened and parents will be approached for enrollment in the study. After consent and baseline screening of parents and infants, eligible infants will undergo an NMT.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single NMT | Experimental | Biological: Nasal Microbiota Transplant (NMT)Swab parent nares then insert swab directly into child nares once. |
| Repeat NMT | Experimental | Biological: Nasal Microbiota Transplant (NMT)Swab parents nares then insert swab directly into child nares multiple times. |
| Placebo | Placebo comparator | Biological: PlaceboInsert a sterile swab into child nares. |
Who may qualify
- Ages
- 0 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Child has had a prior nasal surveillance culture grow S. aurues
- Child is <18 years of age
- 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
- Child has anticipated hospital length of stay >3 days after completing intranasal mupirocin treatment
- Infant >25 weeks gestation unless >2 months chronological age
Key exclusion criteria (14 listed)
- Child is a ward of the State
- Child with a diagnosis of immunodeficiency or antenatal suspicion for immunodeficiency (e.g., sibling with known immunodeficiency, genetic syndrome with known associated immunodeficiency)
- Child cannot have nasal swabs collected (due to anatomic or other clinical intervention, including nasal packing)
- Donor had positive COVID-19 test in prior 21 days
- Donor with signs or symptoms of respiratory illness (e.g. runny nose, congestion, fever, cough)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal Microbiota Transplant (NMT)nasal microbiota transplant | Biological | Repeat NMT, Single NMT |
| PlaceboPlacebo sterile swab | Biological | Placebo |
Primary outcome
Pediatric nasal microbiome diversity after parent-to-child NMT.
Time frame: Day 2, 4, 7, 10, 14 days post-intervention
This outcome will be determined by analysis of periodic surveillance swabs collected after intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aaron M Milstone, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nasal Microbiota Transplant (NMT) in people with Staphylococcal Aureus Infection and Microbial Colonization, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danielle Koontz, Research Manager (4432879040, dkoontz1@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric nasal microbiome diversity after parent-to-child NMT. (time frame: Day 2, 4, 7, 10, 14 days post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.