Actively Recruiting
Comparing Single Versus Repeat Parent-to-Child Nasal Microbiome Transplant on Seeding, Engraftment, and Diversity of the Neonatal Nasal Microbiome
Led by Johns Hopkins University · Updated on 2026-06-08
175
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether a nasal microbiota transplant (NMT) from parent to child can successfully transfer and establish beneficial bacteria in the noses of newborns, increasing the variety of microbes. This study focuses on neonates admitted to a neonatal intensive care unit (NICU), aiming to learn how different NMT approaches affect the baby's nasal microbiome. The study compares three groups: one receiving a single NMT, another receiving multiple NMTs, and a control group receiving a placebo sterile swab. Parents' nasal bacteria are collected and then transferred to the newborn's nose either once or multiple times, depending on the group. This transplant process is done after screening and consent. The research is conducted under phase 1 conditions, with random assignment but no masking. Participants and their parents will be monitored over two weeks after treatment, with nasal samples collected on days 2, 4, 7, 10, and 14 to measure the diversity of the neonatal nasal microbiome. The study involves screening for infections, consent procedures, and careful observation of the microbiome changes. The total age range for participants is from birth up to 60 years for parent providers, and the study runs through the end of 2026.
CONDITIONS
Brief Title
Comparing Single Versus Repeat NMT on the Diversity of the Neonatal Nasal Microbiome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Neonate has an expected NICU stay longer than 7 days
- Neonate is at least 25 weeks gestation
- At least one parent or adult provider is not colonized with Staphylococcus aureus
- Neonate is not colonized with Staphylococcus aureus on baseline screening
- Parent or adult provider is able to provide informed consent
You will not qualify if you...
- Neonate has had a prior culture positive for Staphylococcus aureus
- Neonate is a ward of the State
- Neonate suspected antenatally of having immunodeficiency
- Neonate cannot have nasal swabs collected due to anatomy or clinical interventions
- Parent or adult provider tested positive for COVID-19 in the past 21 days
- Parent or adult provider has respiratory illness symptoms
- Parent or adult provider had recent close contact with respiratory infection
- Parent or adult provider tests positive for Staphylococcus aureus colonization
- Parent or adult provider tests positive for respiratory pathogens
- Parent or adult provider cannot provide written informed consent
- Parent or adult provider cannot be present at bedside during intervention
- Parent or adult provider has chronic sinusitis, cystic fibrosis, or multi-drug resistant infection
- Parent or adult provider unable or unwilling to complete donor questionnaire or has positive responses on it
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single intervention or multiple interventions over several days
Eligible neonates receive a nasal microbiota transplant or placebo as assigned by randomization.
1 to multiple visits depending on assigned intervention
Duration - 14 days post-intervention
Participants are monitored for nasal microbiome diversity through scheduled assessments after intervention.
5 visits on Days 2, 4, 7, 10, and 14 post-intervention
Trial Site Locations
Total: 1 location
1
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
D
Danielle Koontz
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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