Comparing Single Versus Repeat NMT on the Diversity of th... | NCT06283355

Studies
Comparing Single Versus Repeat NMT on the Diversity of the Neonatal Nasal Microbiome

NCT06283355

Sponsor

Johns Hopkins University

Status

Recruiting

Last Update Posted

Jun 8, 2026Actual

Enrollment

175Estimated

Phase

Phase 1

Conditions

Staphylococcus Aureus
Microbial Colonization
Neonatal Infection

Interventions

Nasal Microbiota Transplant (NMT)
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 3, 2024Actual

Primary Completion Date

Sep 1, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Feb 21, 2024

First Submission Date that Met QC Criteria

Feb 21, 2024

First Posted Date

Feb 28, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 4, 2026

Last Update Posted Date

Jun 8, 2026Actual

Description Module

Brief Summary

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

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. Neonates 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 neonates, eligible neonates will undergo an NMT.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

175Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single NMT	Experimental	Swab parent nares then insert swab directly into neonate nares once.	Biological: Nasal Microbiota Transplant (NMT)
Repeat NMT	Experimental	Swab parents nares then insert swab directly into neonate nares multiple times.	Biological: Nasal Microbiota Transplant (NMT)
Placebo	Placebo Comparator	Insert a sterile swab into neonate nares.	Biological: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nasal Microbiota Transplant (NMT)	Biological	nasal microbiota transplant	Repeat NMT Single NMT

Measure	Description	Time Frame
Neonatal nasal microbiome diversity after intervention	This outcome will be determined by analysis of periodic surveillance swabs collected after intervention.	Day 2, 4, 7, 10, 14 days post-intervention

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D013203	Staphylococcal Infections
D003141	Communicable Diseases

ID	Term
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections