Nasal Microbiota Transplant for Staphylococcus aureus Colonization

(NMT Protocol 3 Trial)

Overseen By Slade Decker, Senior Research Coordinator

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Johns Hopkins University

Must be taking: Intranasal mupirocin

Disqualifiers: Immunodeficiency, Nasal swab issues, others

Compensation: Varies

Number of Visits: 6

Duration: 1 day

175 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how Nasal Microbiota Transplant (NMT) can alter the bacterial balance in the noses of children treated for Staphylococcus aureus, a common infection-causing bacterium. The trial includes three groups: one receiving a single NMT, another receiving repeated NMTs, and the last receiving a placebo treatment. Eligible children have previously had Staphylococcus aureus in their noses and recently completed treatment with a nasal ointment. As a Phase 1 trial, the research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this protocol is safe for pediatric use?

Research has shown that Nasal Microbiota Transplant (NMT) is being explored for its impact on nasal health. In some studies, participants who received NMT reported improvements in their chronic sinus problems, suggesting that the treatment might be safe and helpful.

However, as this trial is just beginning, detailed safety information may not yet be available. Early trials typically focus on ensuring a treatment's safety for people. If NMT is already being tested in humans, there is some initial belief in its safety. Nonetheless, more research is necessary to fully understand any potential side effects or risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard antibiotics used to manage Staphylococcus aureus colonization, the Nasal Microbiota Transplant (NMT) introduces beneficial bacteria directly into the nasal passages. Researchers are excited about NMT because it leverages the body's natural microbiome to fight harmful bacteria, potentially reducing the need for antibiotics and minimizing the risk of antibiotic resistance. The Single NMT and Repeat NMT arms explore the effectiveness of one-time versus multiple applications, offering insights into optimizing this innovative, non-invasive approach to preventing bacterial colonization.

What evidence suggests that this protocol is effective for Staphylococcus aureus colonization?

Research suggests that Nasal Microbiota Transplant (NMT) might reduce Staphylococcus aureus by increasing bacterial diversity in the nose. One study found that patients experienced significant relief from chronic rhinosinusitis (CRS) symptoms after receiving NMT. This improvement was shown by a lower score on the SNOT-22 test, indicating better nasal health. Additionally, a wider range of nasal bacteria is linked to a lower risk of S. aureus presence. In this trial, participants may receive either a Single NMT or Repeat NMT, where nasal bacteria are transferred from parents to children, to investigate if these positive changes can be achieved. Overall, early results are promising for using NMT to manage nasal bacterial issues. ^{1 2 3 4 6}

Who Is on the Research Team?

Aaron M Milstone, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for children who have had a nasal mupirocin treatment to clear staph infections. They should not currently be sick with an infection or have conditions that affect the immune system.

Inclusion Criteria

Infant has had a prior nasal surveillance culture grow S. aureus

My baby was born after more than 25 weeks of pregnancy.

Donor is able to provide informed consent

Exclusion Criteria

Infant is a ward of the State

Donor tests positive on baseline screening test for a respiratory pathogen

Donor is not able to provide written informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Eligible infants undergo nasal microbiota transplant (NMT) or placebo intervention

1 day

1 visit (in-person)

Follow-up

Participants are monitored for nasal microbiome diversity through periodic surveillance swabs

2 weeks

5 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Nasal Microbiota Transplant (NMT)

Trial Overview

The study tests if Nasal Microbiota Transplant (NMT) can restore the variety of microbes in kids' noses after mupirocin, compared to a placebo group.

How Is the Trial Designed?

Group I: Single NMT Experimental Treatment 1 Intervention

Swab parent nares then insert swab directly into child nares once.

Group II: Repeat NMT Experimental Treatment 1 Intervention

Swab parents nares then insert swab directly into child nares multiple times.

Group III: Placebo Placebo Group 1 Intervention

Insert a sterile swab into child nares.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Citations

1.

withpower.com

withpower.com/trial/nasal-microbiota-transplant-for-staphylococcus-aureus-colonization-16a70

Nasal Microbiota Transplant for Staphylococcus aureus ...

What data supports the effectiveness of the treatment Nasal Microbiota Transplant (NMT) for Staphylococcus aureus colonization? The research suggests that ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S0966842X24003263

Nasal microbiota transplantation: a gateway to novel ...

Patients reported significant improvements in CRS symptoms 3 months post-NMT, as evidenced by a reduced sino-nasal outcome test (SNOT-22) score, compared with ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06283355?cond=Parents+and+Children&aggFilters=status%3Arec

Comparing Single Versus Repeat NMT on the Diversity of ...

This study aims to determine whether a parent-to-child nasal microbiota transplant (NMT) can seed and engraft parental organisms into the ...

4.

nature.com

nature.com/articles/s41564-025-02120-6

Nasal Staphylococcus aureus carriage promotes ...

Here, using human data and experiments in mice, we show that nasal Staphylococcus aureus is linked to depression. Nasal microbiome analyses ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8507450/

Low Diversity in Nasal Microbiome Associated With ...

Neonates who acquired S. aureus colonization had lower alpha diversity (Wilcoxon rank-sum test P < .05) and differed in beta diversity (omnibus MiRKAT P = .002)

6.

journals.plos.org

journals.plos.org/plosone/article?id=10.1371/journal.pone.0316460

Nasal microbiota predictors for methicillin resistant ...

We determined the prevalence and identified nasal microbiome predictors for methicillin-resistant Staphylococcus colonization at the time of PICU admission.