Feasibility and Safety Study of Parent-to-Child Nasal Microbiota Transplant
NCT05695196 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34
Last updated 2025-12-11
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.
Conditions
- Staphylococcus Aureus
- Microbial Colonization
- Neonatal Infection
Interventions
- BIOLOGICAL
-
nasal microbiota transplant (NMT)
nasal microbiota transplant
- BIOLOGICAL
-
Placebo sterile saline
Sponsors & Collaborators
-
National Institute of Allergy and Infectious Diseases (NIAID)
collaborator NIH - lead OTHER
Principal Investigators
-
Aaron Milstone · Johns Hopkins University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-10-25
- Primary Completion
- 2025-05-06
- Completion
- 2026-12-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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