Parent-to-Child Nasal Microbiota Transplant to Promote Colonization Resistance to Staphylococcus Aureus

January 12, 2023 updated by: Johns Hopkins University

Pilot Study of Parent-to-Child Nasal Microbiota Transplant to Promote Colonization Resistance to Staphylococcus Aureus

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.

Study Overview

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 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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University
        • Contact:
        • Principal Investigator:
          • Aaron Milstone

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: direct NMT
swab parent nares then insert swab directly into neonate nares
nasal microbiota transplant
Experimental: indirect NMT
swab parent nares, inoculate swab into saline, instill liquid into neonate nares
nasal microbiota transplant
Placebo Comparator: placebo
instill sterile saline into neonate nares
Placebo sterile saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 7, 14 days post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Aaron Milstone, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2023

Primary Completion (Anticipated)

September 1, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

January 12, 2023

First Submitted That Met QC Criteria

January 12, 2023

First Posted (Actual)

January 23, 2023

Study Record Updates

Last Update Posted (Actual)

January 23, 2023

Last Update Submitted That Met QC Criteria

January 12, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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