Comparing Single Versus Repeat NMT on the Diversity of the Neonatal Nasal Microbiome
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age0-60
SponsorJohns Hopkins University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Nasal Microbiota Transplant (NMT)
Biological/Vaccinenasal microbiota transplant
Placebo
Biological/VaccinePlacebo sterile swab
Treatment groups
175 Participants
are divided into 3 treatment groupsGroup A: Single NMTExperimental treatment 1 intervention
Group B: Repeat NMTExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Neonatal nasal microbiome diversity after intervention
This outcome will be determined by analysis of periodic surveillance swabs collected after intervention.
Time frame
Day 2, 4, 7, 10, 14 days post-interventionSponsors and contacts
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Source ClinicalTrials.gov