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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06283355
Other study ID # IRB00433691
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date May 15, 2024
Est. completion date December 31, 2026

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
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 175
Est. completion date December 31, 2026
Est. primary completion date June 1, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 0 Years 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

Study Design


Intervention

Biological:
Nasal Microbiota Transplant (NMT)
nasal microbiota transplant
Placebo
Placebo sterile swab

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 2, 4, 7, 10, 14 days post-intervention
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