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Microbiota Transplant
Nasal Bacteria Transfer for Neonatal Infections
Phase 1
Recruiting
Led By Aaron Milstone, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Neonate ≥25 weeks gestation
Be younger than 65 years old
Must not have
Parent/adult provider with signs or symptoms of respiratory illness (e.g. runny nose, congestion, fever, cough)
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?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 2, 4, 7, 10, 14 days post-intervention
Summary
This trial will investigate if transferring nasal bacteria from parents to newborns can introduce the parents' bacteria into the newborns' microbiome and improve the diversity of bacteria in the newborns.
Who is the study for?
This trial is for newborns at risk of nasal infections. It's testing if a parent-to-child nasal microbiota transplant (NMT) can transfer healthy bacteria from parents to their baby to boost the baby's immune system.
What is being tested?
The study compares two groups: one receives a single NMT, while the other gets repeated NMTs. The goal is to see which method better increases the diversity of good bacteria in babies' noses.
What are the potential side effects?
Potential side effects may include temporary discomfort or irritation in the baby’s nose, and there's a small chance of transferring harmful bacteria along with the good ones.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My baby was born at or after 25 weeks of pregnancy.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am experiencing symptoms like a runny nose, congestion, fever, or cough.
Select...
I've been near someone with a cold or flu in the past week.
Select...
My child's caregiver cannot be with them during their treatment.
Select...
I have a history of chronic sinusitis, cystic fibrosis, or an infection resistant to multiple drugs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 2, 4, 7, 10, 14 days post-intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 2, 4, 7, 10, 14 days post-intervention
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Neonatal nasal microbiome diversity after intervention
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Single NMTExperimental Treatment1 Intervention
Swab parent nares then insert swab directly into neonate nares once.
Group II: Repeat NMTExperimental Treatment1 Intervention
Swab parents nares then insert swab directly into neonate nares multiple times.
Group III: PlaceboPlacebo Group1 Intervention
Insert a sterile swab 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
2,339 Previous Clinical Trials
14,881,611 Total Patients Enrolled
Aaron Milstone, MDPrincipal InvestigatorJohns Hopkins University