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

Phase 1

Active, not recruiting

• Conditions: Staphylococcus Aureus; Microbial Colonization; Neonatal Infection
• Interventions: Biological: Placebo; Biological: nasal microbiota transplant (NMT)

• Registration Number: NCT05695196
• Lead 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.

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 Timeline

• Study First Submitted: 2023-01-12
• Study First Submitted QC: 2023-01-12
• Study First Posted: 2023-01-23
• Study Start: 2023-10-25
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-25
• Last Update Posted: 2024-07-29
• Primary Completion: 2025-06-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Neonate:

1. Neonate has anticipated NICU 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 respiratory illness (e.g. runny nose, congestion, fever, cough)
3. 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?
4. Parent/adult provider tests positive on baseline screening test for S. aureus nasal colonization.
5. Parent/adult provider tests positive on baseline screening test for a respiratory pathogen.
6. Parent/adult provider is not able to provide written informed consent
7. Parent/adult provider is not able to be present at the bedside at the time of intervention.
8. Parent/adult provider has history of chronic sinusitis, cystic fibrosis, or an infection with a multi-drug resistant organism.
9. Inability or unwillingness to complete the Donor questionnaire or a positive response to any question on the Donor questionnaire

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	instill sterile saline into neonate nares
indirect NMT	nasal microbiota transplant (NMT)	swab parent nares, inoculate swab into saline, instill liquid into neonate nares
direct NMT	nasal microbiota transplant (NMT)	swab parent nares then insert swab directly into neonate nares

Primary Outcome Measures

Name	Time	Method
Neonatal nasal microbiome diversity after intervention	Day 4, 7, 10, 14 days post-intervention	This outcome will be determined by analysis of periodic surveillance swabs collected after intervention.

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States