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

Microbial Colonization Clinical Trial

— ParentsTREAT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05695196
• Other study ID #: IRB00361302
• Status: Recruiting
• Phase: Phase 1
• Start date: October 25, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: May 2024
• Source: Johns Hopkins University
• Contact: Danielle Koontz
• Phone: 443-287-9040
• Email: dkoontz1[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Microbial Colonization
• Neonatal Infection
• Staphylococcus Aureus

Intervention

Biological:
• nasal microbiota transplant (NMT)
nasal microbiota transplant
• Placebo
Placebo sterile saline

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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