NCT06283355

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

Comparing Single Versus Repeat Parent-to-Child Nasal Microbiome Transplant on Seeding, Engraftment, and Diversity of the Neonatal Nasal Microbiome

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 175 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 0 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Staphylococcus Aureus
• Microbial Colonization
• Neonatal Infection

Interventions

Type	Name	Description
BIOLOGICAL	Nasal Microbiota Transplant (NMT)	nasal microbiota transplant
BIOLOGICAL	Placebo	Placebo sterile swab

Timeline

• Start date: 2024-09-03
• Primary completion: 2026-06-01
• Completion: 2026-12-31
• First posted: 2024-02-28
• Last updated: 2025-09-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study