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

NCT05695196 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: IRB00361302R21AI179644
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Staphylococcus Aureus; Neonatal Infection; Microbial Colonization

Keywords

microbiome

Outcome Measures

Primary Outcomes (1)

• Neonatal nasal microbiome diversity after intervention

  This outcome will be determined by analysis of periodic surveillance swabs collected after intervention.

  Day 4, 7, 10, 14 days post-intervention

Study Arms (3)

direct NMT

EXPERIMENTAL

swab parent nares then insert swab directly into neonate nares

Biological: nasal microbiota transplant (NMT)

indirect NMT

EXPERIMENTAL

swab parent nares, inoculate swab into saline, instill liquid into neonate nares

Biological: nasal microbiota transplant (NMT)

placebo

PLACEBO COMPARATOR

instill sterile saline into neonate nares

Biological: Placebo

Interventions

nasal microbiota transplant (NMT) BIOLOGICAL

nasal microbiota transplant

direct NMT; indirect NMT

Placebo BIOLOGICAL

Placebo sterile saline

placebo

Eligibility Criteria

• Age: Up to 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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:
• \. Parent/adult provider is able to provide informed consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Staphylococcal Infections; Communicable Diseases

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Aaron Milstone

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: January 23, 2023
• Study Start: October 25, 2023
• Primary Completion: May 6, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 11, 2025

Record last verified: 2025-12

Locations

US (1)