NCT05695196

Feasibility and Safety Study of Parent-to-Child Nasal Microbiota Transplant

Feasibility and Safety Study of Parent-to-Child Nasal Microbiota Transplant to Promote Colonization Resistance to Staphylococcus Aureus

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

Summary

This feasibility and safety pilot study looks to determine whether transferring a parents healthy, diverse nasal microbiota to the participant's infant(s) will create a healthy, diverse neonatal nasal microbiome.

Detailed description

The parent-to-child NMT study is a pilot study to test the feasibility of a parent-to-child nasal microbiome transplant. The investigators will test parent-to-neonate nasal microbiome transplantation as an intervention to reduce S. aureus acquisition in neonates. Neonates admitted to the Johns Hopkins Hospital 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 a nasal microbiome transplant. This pilot study looks to determine whether transferring a parents healthy, diverse nasal microbiota to the infant(s) will create a healthy, diverse neonatal nasal microbiome. The investigators are planning an upcoming randomized controlled trial of this intervention and hope to establish feasibility during this pilot study.

Conditions

• Staphylococcus Aureus
• Microbial Colonization
• Neonatal Infection

Interventions

Type	Name	Description
BIOLOGICAL	nasal microbiota transplant (NMT)	nasal microbiota transplant
BIOLOGICAL	Placebo	Placebo sterile saline

Timeline

• Start date: 2023-10-25
• Primary completion: 2025-05-06
• Completion: 2026-12-01
• First posted: 2023-01-23
• Last updated: 2025-12-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study