Staphylococcus AureusPhase 1ParentsTREATNCT05695196
Feasibility and Safety Study of Parent-to-Child Nasal Microbiota Transplant
A Phase 1 study testing nasal microbiota transplant (NMT) in people with Staphylococcus Aureus and Microbial Colonization, run by Johns Hopkins University at 1 site in United States.
Trial summary
This feasibility and safety pilot study looks to determine whether transferring a parents healthy, diverse nasal microbiota to the participant's infant(s) will create a healthy, diverse neonatal nasal microbiome. Read more about this study
- Who is it for?
- Ages Up to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Staphylococcus Aureus, Microbial Colonization, Neonatal Infection
- What is being tested?
- nasal microbiota transplant (NMT)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2023to 1 Dec 2026
- 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 Up to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Neonate:
- Neonate has anticipated NICU length of stay > 7 days
- Neonate ≥25 weeks gestation
- At least one parent/adult provider not colonized with S. aureus (as determined by baseline screening)
- Neonate is not colonized with S. aureus on baseline screening
- Parent/adult provider:
- 1. Parent/adult provider is able to provide informed consent.
Who cannot join
- Neonate:
- Neonate has had a prior clinical or surveillance culture grow S. aureus
- Neonate is a ward of the State
- Neonate with antenatal suspicion for immunodeficiency (e.g. sibling with known immunodeficiency, genetic syndrome with known associated immunodeficiency)
- Neonate cannot have nasal swabs collected (due to anatomic or other clinical intervention, including nasal packing)
- Parent/adult Provider:
Show all 15Show fewer
- Parent/adult provider had positive COVID-19 test in prior 21 days
- Parent/adult provider with signs or symptoms of respiratory illness (e.g. runny nose, congestion, fever, cough)
- 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?
- Parent/adult provider tests positive on baseline screening test for S. aureus nasal colonization.
- Parent/adult provider tests positive on baseline screening test for a respiratory pathogen.
- Parent/adult provider is not able to provide written informed consent
- Parent/adult provider is not able to be present at the bedside at the time of intervention.
- Parent/adult provider 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Safety Study of Parent-to-Child Nasal Microbiota Transplant to Promote Colonization Resistance to Staphylococcus Aureus
This feasibility and safety pilot study looks to determine whether transferring a parents healthy, diverse nasal microbiota to the participant's infant(s) will create a healthy, diverse neonatal nasal microbiome.
Read the detailed description
The parent-to-child NMT study is a pilot study to test the feasibility of a parent-to-child nasal microbiome transplant. The investigators will test parent-to-neonate nasal microbiome transplantation as an intervention to reduce S. aureus acquisition in neonates. Neonates admitted to the Johns Hopkins Hospital 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 neonates, eligible neonates will undergo a nasal microbiome transplant. This pilot study looks to determine whether transferring a parents healthy, diverse nasal microbiota to the infant(s) will create a healthy, diverse neonatal nasal microbiome. The investigators are planning an upcoming randomized controlled trial of this intervention and hope to establish feasibility during this pilot study.
- Being tested
- nasal microbiota transplant (NMT), Placebo
- Keywords
- microbiome
- Medical subject headings
- Staphylococcal Infections, Communicable Diseases
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 saline
| Study group | Role | What they receive |
|---|---|---|
| direct NMT | Experimental | swab parent nares then insert swab directly into neonate nares Receives: Biological: nasal microbiota transplant (NMT) |
| indirect NMT | Experimental | swab parent nares, inoculate swab into saline, instill liquid into neonate nares Receives: Biological: nasal microbiota transplant (NMT) |
| placebo | Placebo comparator | instill sterile saline into neonate nares Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal nasal microbiome diversity after intervention
This outcome will be determined by analysis of periodic surveillance swabs collected after intervention.
Measured: Day 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 posted23 Jan 2023
- Study start25 Oct 2023
- Primary completion6 May 2025
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcus AureusStudies 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aaron Milstone, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05695196
- Sponsor's protocol ID
- IRB00361302
- Other IDs
- R21AI179644
- Acronym
- ParentsTREAT
- Status last verified
- Dec 2025
- First submitted
- 12 Jan 2023
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety Study of Parent-to-Child Nasal Microbiota Transplant to Promote Colonization Resistance to Staphylococcus Aureus
- ClinicalTrials.gov ID
- NCT05695196
- Acronym / sponsor ID
- ParentsTREAT / IRB00361302
- Keywords
- microbiome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 6 May 2025 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 23 Jan 2023 (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 feasibility and safety pilot study looks to determine whether transferring a parents healthy, diverse nasal microbiota to the participant's infant(s) will create a healthy, diverse neonatal nasal microbiome.
Detailed description
The parent-to-child NMT study is a pilot study to test the feasibility of a parent-to-child nasal microbiome transplant. The investigators will test parent-to-neonate nasal microbiome transplantation as an intervention to reduce S. aureus acquisition in neonates. Neonates admitted to the Johns Hopkins Hospital 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 neonates, eligible neonates will undergo a nasal microbiome transplant. This pilot study looks to determine whether transferring a parents healthy, diverse nasal microbiota to the infant(s) will create a healthy, diverse neonatal nasal microbiome. The investigators are planning an upcoming randomized controlled trial of this intervention and hope to establish feasibility during this pilot study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| direct NMT | Experimental | Biological: nasal microbiota transplant (NMT)swab parent nares then insert swab directly into neonate nares |
| indirect NMT | Experimental | Biological: nasal microbiota transplant (NMT)swab parent nares, inoculate swab into saline, instill liquid into neonate nares |
| placebo | Placebo comparator | Biological: Placeboinstill sterile saline into neonate nares |
Who may qualify
- Ages
- Up to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Neonate has anticipated NICU length of stay > 7 days
- Neonate ≥25 weeks gestation
- At least one parent/adult provider not colonized with S. aureus (as determined by baseline screening)
- Neonate is not colonized with S. aureus on baseline screening
- 1. Parent/adult provider is able to provide informed consent.
Key exclusion criteria (15 listed)
- Neonate has had a prior clinical or surveillance culture grow S. aureus
- Neonate is a ward of the State
- Neonate with antenatal suspicion for immunodeficiency (e.g. sibling with known immunodeficiency, genetic syndrome with known associated immunodeficiency)
- Neonate cannot have nasal swabs collected (due to anatomic or other clinical intervention, including nasal packing)
- Parent/adult provider had positive COVID-19 test in prior 21 days
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 | direct NMT, indirect NMT |
| PlaceboPlacebo sterile saline | Biological | placebo |
Primary outcome
Neonatal nasal microbiome diversity after intervention
Time frame: Day 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 11 Dec 2025.
Related trials for Staphylococcus Aureus
RecruitingObservational study
Study of the Nasal Intracellular Reservoir of Staphylococcus Aureus in Patients With S. Aureus Bacteremia
Bacteria Infection Mechanism
Not yet recruiting
Farm-originated Antimicrobial Resistance Modeling: Exploring Humans-to-Animal Dissemination
Methicillin-Resistant Staphylococcus Aureus Colonization
RecruitingPhase 2
Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia
Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Septicemia
Active, not recruitingPhase 1/2
A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
Staphylococcus Aureus
Not yet recruiting
Bacterial Decolonization to Prevent Severe Radiation Dermatitis in Head and Neck Squamous Cell Carcinoma
HNSCC
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. This study is not recruiting at the moment.
Aaron Milstone 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 Staphylococcus Aureus 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 15 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: under way, not looking for participants, as of the sponsor's last update on 11 Dec 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal nasal microbiome diversity after intervention (time frame: Day 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 11 Dec 2025.