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

NCT ID: NCT05695196

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-25
• Study Completion Date: 2026-12-01

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

direct NMT

swab parent nares then insert swab directly into neonate nares

Group Type: EXPERIMENTAL

nasal microbiota transplant (NMT)

Intervention Type: BIOLOGICAL

nasal microbiota transplant

indirect NMT

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

Group Type: EXPERIMENTAL

nasal microbiota transplant (NMT)

Intervention Type: BIOLOGICAL

nasal microbiota transplant

placebo

instill sterile saline into neonate nares

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Placebo sterile saline

Interventions

nasal microbiota transplant (NMT)

nasal microbiota transplant

Intervention Type: BIOLOGICAL

Placebo

Placebo sterile saline

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

Neonate:

1. Neonate has anticipated NICU length of stay > 7 days

2. Neonate ≥25 weeks gestation

3. At least one parent/adult provider not colonized with S. aureus (as determined by baseline screening)

4. 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:

1. Neonate has had a prior clinical or surveillance culture grow S. aureus

2. Neonate is a ward of the State

3. Neonate with antenatal suspicion for immunodeficiency (e.g. sibling with known immunodeficiency, genetic syndrome with known associated immunodeficiency)

4. Neonate cannot have nasal swabs collected (due to anatomic or other clinical intervention, including nasal packing)

Parent/adult Provider:

1. Parent/adult provider had positive COVID-19 test in prior 21 days

2. Parent/adult provider with signs or symptoms of respiratory illness (e.g. runny nose, congestion, fever, cough)

3. 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?

4. Parent/adult provider tests positive on baseline screening test for S. aureus nasal colonization.

5. Parent/adult provider tests positive on baseline screening test for a respiratory pathogen.

6. Parent/adult provider is not able to provide written informed consent

7. Parent/adult provider is not able to be present at the bedside at the time of intervention.

8. Parent/adult provider has history of chronic sinusitis, cystic fibrosis, or an infection with a multi-drug resistant organism.

9. Inability or unwillingness to complete the Donor questionnaire or a positive response to any question on the Donor questionnaire

• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aaron Milstone

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

R21AI179644

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00361302

Identifier Type: -

Identifier Source: org_study_id