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

Primary Purpose

Staphylococcus Aureus, Microbial Colonization, Neonatal Infection

Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
nasal microbiota transplant (NMT)
Placebo
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Staphylococcus Aureus focused on measuring microbiome

Eligibility Criteria

undefined - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Neonate: Neonate has anticipated neonatal intensive care unit 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 a current or recent (last 7 days) respiratory illness (e.g. runny nose, congestion, fever, cough), 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 virus, 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.

Sites / Locations

  • Johns Hopkins University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

direct NMT

indirect NMT

placebo

Arm Description

swab parent nares then insert swab directly into neonate nares

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

instill sterile saline into neonate nares

Outcomes

Primary Outcome Measures

Change in nasal microbiome diversity as assessed by linear discriminant analysis
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.

Secondary Outcome Measures

Full Information

First Posted
January 12, 2023
Last Updated
September 8, 2023
Sponsor
Johns Hopkins University
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT05695196
Brief Title
Parent-to-Child Nasal Microbiota Transplant to Promote Colonization Resistance to Staphylococcus Aureus
Official Title
Pilot Study of Parent-to-Child Nasal Microbiota Transplant to Promote Colonization Resistance to Staphylococcus Aureus
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
June 1, 2026 (Anticipated)
Study Completion Date
December 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Staphylococcus Aureus, Microbial Colonization, Neonatal Infection
Keywords
microbiome

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
direct NMT
Arm Type
Experimental
Arm Description
swab parent nares then insert swab directly into neonate nares
Arm Title
indirect NMT
Arm Type
Experimental
Arm Description
swab parent nares, inoculate swab into saline, instill liquid into neonate nares
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
instill sterile saline into neonate nares
Intervention Type
Biological
Intervention Name(s)
nasal microbiota transplant (NMT)
Intervention Description
nasal microbiota transplant
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo sterile saline
Primary Outcome Measure Information:
Title
Change in nasal microbiome diversity as assessed by linear discriminant analysis
Description
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.
Time Frame
Day 7, 14 days post-intervention

10. Eligibility

Sex
All
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Neonate: Neonate has anticipated neonatal intensive care unit 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 a current or recent (last 7 days) respiratory illness (e.g. runny nose, congestion, fever, cough), 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 virus, 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Danielle Koontz
Phone
410-287-0486
Email
dkoontz1@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron Milstone
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danielle Koontz
Phone
410-287-0486
Email
dkoontz1@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Aaron Milstone

12. IPD Sharing Statement

Learn more about this trial

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

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