Administering NMT to Reestablish Infant Nasal Microbiome Diversity Following Intranasal Mupirocin Treatment

Phase 1

Not yet recruiting

• Conditions: Staphylococcal Aureus Infection; Microbial Colonization; Pediatric Infection; S. Aureus Colonization; Microbial Transplant
• Interventions: Biological: Nasal Microbiota Transplant (NMT); Biological: Placebo

• Registration Number: NCT06805994
• Lead Sponsor: Johns Hopkins University

Brief Summary

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 Timeline

• Study First Submitted: 2025-01-28
• Study First Submitted QC: 2025-01-28
• Study First Posted: 2025-02-03
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-10
• Study Start: 2025-06
• Primary Completion: 2027-01-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single NMT	Nasal Microbiota Transplant (NMT)	Swab parent nares then insert swab directly into neonate nares once.
Repeat NMT	Nasal Microbiota Transplant (NMT)	Swab parents nares then insert swab directly into neonate nares multiple times.
Placebo	Placebo	Insert a sterile swab into neonate nares.

Primary Outcome Measures

Name	Time	Method
Neonatal nasal microbiome diversity after parent-to-child NMT.	Day 2, 4, 7, 10, 14 days post-intervention	This outcome will be determined by analysis of periodic surveillance swabs collected after intervention.

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States