← Back to Search

Microbiota Transplant

Nasal Microbiota Transplant for Preventing Newborn Infections (ParentsTREAT Trial)

Phase 1
Recruiting
Led By Aaron Milstone
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 4, 7, 10, 14 days post-intervention
Awards & highlights

ParentsTREAT Trial Summary

This trial aims to see if transferring good bacteria from parent to baby can help create a healthy nasal microbiome in newborns.

Who is the study for?
This trial is for newborns who are expected to stay in the neonatal intensive care unit for over a week and are at least 25 weeks gestation. They must not be colonized with S. aureus, nor should their parent/provider, who also needs to consent and be free of respiratory illness or recent COVID-19.Check my eligibility
What is being tested?
The study tests if transferring healthy nasal microbiota from a parent to their infant can establish a diverse nasal microbiome in the baby. Infants will either receive this nasal microbiota transplant (NMT) or a placebo.See study design
What are the potential side effects?
As this is a feasibility and safety study, specific side effects aren't listed but may include potential risks associated with altering an infant's nasal microbial environment.

ParentsTREAT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 4, 7, 10, 14 days post-intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 4, 7, 10, 14 days post-intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Neonatal nasal microbiome diversity after intervention

ParentsTREAT Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: indirect NMTExperimental Treatment1 Intervention
swab parent nares, inoculate swab into saline, instill liquid into neonate nares
Group II: direct NMTExperimental Treatment1 Intervention
swab parent nares then insert swab directly into neonate nares
Group III: placeboPlacebo Group1 Intervention
instill sterile saline into neonate nares

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,274 Previous Clinical Trials
14,840,317 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,277 Previous Clinical Trials
5,487,253 Total Patients Enrolled
Aaron MilstonePrincipal InvestigatorJohns Hopkins University

Media Library

Nasal Microbiota Transplant (Microbiota Transplant) Clinical Trial Eligibility Overview. Trial Name: NCT05695196 — Phase 1
Staph Infection Research Study Groups: placebo, indirect NMT, direct NMT
Staph Infection Clinical Trial 2023: Nasal Microbiota Transplant Highlights & Side Effects. Trial Name: NCT05695196 — Phase 1
Nasal Microbiota Transplant (Microbiota Transplant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05695196 — Phase 1
~126 spots leftby Jun 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top