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NCT05695196 | Recruiting | Staphylococcus Aureus

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

Johns Hopkins University

Brief 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.

Condition or disease

Staphylococcus Aureus

Microbial Colonization

Neonatal Infection

Intervention/treatment

nasal microbiota transplant (NMT)

Placebo

Phase

Phase 1

Detailed 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.}}

Study Type : Interventional
Estimated Enrollment : 200 participants
Masking : None (Open Label)
Primary Purpose : Prevention
Official Title : Feasibility and Safety Study of Parent-to-Child Nasal Microbiota Transplant to Promote Colonization Resistance to Staphylococcus Aureus
Actual Study Start Date : October 25, 2023
Estimated Primary Completion Date : June 1, 2026
Estimated Study Completion Date : December 1, 2026
Arm Intervention/treatment

Experimental: direct NMT

swab parent nares then insert swab directly into neonate nares

Biological: nasal microbiota transplant (NMT)

Experimental: indirect NMT

swab parent nares, inoculate swab into saline, instill liquid into neonate nares

Biological: nasal microbiota transplant (NMT)

Placebo Comparator: placebo

instill sterile saline into neonate nares

Biological: Placebo
Ages Eligible for Study: to 60 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
Inclusion Criteria
  • Neonate
    • 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
    • Parent/adult provider
      • 1. Parent/adult provider is able to provide informed consent.
      Exclusion Criteria
      • Neonate
        • 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)
        • Parent/adult Provider
          • Parent/adult provider had positive COVID-19 test in prior 21 days
          • Parent/adult provider with signs or symptoms of respiratory illness (e.g. runny nose, congestion, fever, cough)
          • 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?
          • Parent/adult provider tests positive on baseline screening test for S. aureus nasal colonization.
          • Parent/adult provider tests positive on baseline screening test for a respiratory pathogen.
          • Parent/adult provider is not able to provide written informed consent
          • Parent/adult provider is not able to be present at the bedside at the time of intervention.
          • Parent/adult provider has history of chronic sinusitis, cystic fibrosis, or an infection with a multi-drug resistant organism.
          • Inability or unwillingness to complete the Donor questionnaire or a positive response to any question on the Donor questionnaire
Feasibility and Safety Study of Parent-to-Child Nasal Microbiota Transplant

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

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Locations

Recruiting

United States, Maryland

Johns Hopkins University

Baltimore, Maryland, United States, 21287