This 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.
Full Title of Study: “Pilot Study of Parent-to-Child Nasal Microbiota Transplant to Promote Colonization Resistance to Staphylococcus Aureus”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Prevention
- Masking: None (Open Label)
- Study Primary Completion Date: September 1, 2025
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 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 participant's infant(s) will create a healthy, diverse neonatal nasal microbiome.
- Biological: nasal microbiota transplant (NMT)
- nasal microbiota transplant
- Biological: Placebo
- Placebo sterile saline
Arms, Groups and Cohorts
- Experimental: direct NMT
- swab parent nares then insert swab directly into neonate nares
- Experimental: indirect NMT
- swab parent nares, inoculate swab into saline, instill liquid into neonate nares
- Placebo Comparator: placebo
- instill sterile saline into neonate nares
Clinical Trial Outcome Measures
- Change in nasal microbiome diversity as assessed by linear discriminant analysis
- Time Frame: Day 7, 14 days post-intervention
- We will perform linear discriminant analysis to identify differentially abundant microbial species between the groups. Alpha diversity metrics between NMT and placebo groups will be tested with bidirectional Wilcoxon test to compare alpha diversity metrics between 1) direct NMT and placebo group, 2) indirect NMT and placebo group, 3) direct NMT and indirect NMT groups.
Participating in This Clinical Trial
Neonate: 1. Neonate has anticipated neonatal intensive care unit 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 a current or recent (last 7 days) respiratory illness (e.g. runny nose, congestion, fever, cough), 3. Parent/adult provider tests positive on baseline screening test for S. aureus nasal colonization, 4. Parent/adult provider tests positive on baseline screening test for a respiratory virus, 5. Parent/adult provider is not able to provide written informed consent, 6. Parent/adult provider is not able to be present at the bedside at the time of intervention, 7. Parent/adult provider has history of chronic sinusitis, cystic fibrosis, or an infection with a multi-drug resistant organism.
Gender Eligibility: All
Minimum Age: N/A
Maximum Age: 60 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Johns Hopkins University
- National Institute of Allergy and Infectious Diseases (NIAID)
- Provider of Information About this Clinical Study
- Overall Official(s)
- Aaron Milstone, Principal Investigator, Johns Hopkins University
- Overall Contact(s)
- Danielle Koontz, 410-287-0486, firstname.lastname@example.org
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