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

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

• Status: Not yet recruiting
• Conditions: Staphylococcus Aureus; Microbial Colonization; Neonatal Infection
• Intervention / Treatment: Biological: nasal microbiota transplant (NMT); Biological: Placebo

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

• Study Contact: Name: Danielle Koontz; Phone Number: 410-287-0486; Email: [email protected]

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University
      • Contact: Danielle Koontz; Phone Number: 410-287-0486; Email: [email protected]
      • Principal Investigator: Aaron Milstone

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

• Sponsor: Johns Hopkins University
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: Aaron Milstone, Johns Hopkins University

Study record dates

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

• Keywords: microbiome
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Infections; Communicable Diseases; Staphylococcal Infections
• Other Study ID Numbers: IRB00361302

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