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

Trial Summary

What data supports the effectiveness of the treatment Nasal Microbiota Transplant (NMT) for Staphylococcus aureus colonization?

The research suggests that certain bacteria in the nose, like Dolosigranulum pigrum and Moraxella nonliquefaciens, are linked to lower levels of Staphylococcus aureus, indicating that restoring a healthy nasal microbiota might help reduce S. aureus colonization. ^{1 2 3}

How does Nasal Microbiota Transplant (NMT) differ from other treatments for Staphylococcus aureus colonization?

Nasal Microbiota Transplant (NMT) is unique because it involves transferring beneficial bacteria to the nose to restore a healthy balance, unlike traditional treatments that use antibiotics to kill bacteria, which can disrupt the natural microbiota and lead to rapid recolonization by Staphylococcus aureus. ^{1 2 4 5 6}

What is the purpose of this trial?

This protocol aims to evaluate how NMT affects pediatric nasal microbiome diversity following intranasal mupirocin treatment

Research Team

Aaron M Milstone, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

Group I: Single NMT Experimental Treatment 1 Intervention

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

Group II: Repeat NMT Experimental Treatment 1 Intervention

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

Group III: Placebo Placebo Group 1 Intervention

Insert a sterile swab into neonate nares.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Nasal microbiome disruption and recovery after mupirocin treatment in Staphylococcus aureus carriers and noncarriers. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

The human nasal microbiota and Staphylococcus aureus carriage. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Staphylococcus aureus nasal carriage and microbiome composition among medical students from Colombia: a cross-sectional study. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Adhesion of Staphylococcus aureus to epithelial cells: an in vitro approach to study interactions within the nasal microbiota. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Nasal microenvironments and interspecific interactions influence nasal microbiota complexity and S. aureus carriage. [2022]

6. Chile pubmed.ncbi.nlm.nih.gov

[Nasal carriage, antibiotype and genotype of isolated Staphylococcus aureus from Medicine and Nursing students of Campus San Felipe, University of Valparaiso, Chile, during 2017]. [2022]