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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 4, 7, 10, 14 days post-intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 4, 7, 10, 14 days post-intervention
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
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,266 Previous Clinical Trials
14,837,297 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,270 Previous Clinical Trials
5,485,037 Total Patients Enrolled
Aaron MilstonePrincipal InvestigatorJohns Hopkins University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am experiencing symptoms like a runny nose, congestion, fever, or cough.I've been near someone with a cold or flu in the past week.I have a history of chronic sinusitis, cystic fibrosis, or an infection resistant to multiple drugs.My parent or adult caregiver cannot be with me during the treatment.My newborn might have an immune system problem, similar to a family member.My baby was born at or after 25 weeks of pregnancy.
Research Study Groups:
This trial has the following groups:- Group 1: placebo
- Group 2: indirect NMT
- Group 3: direct NMT
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there opportunities for enrolment in this exploration?
"Via the clinicaltrials.gov website, it is evident that this particular medical trial has stopped seeking new enrollees from the moment of its last update on December 1st 2023. Despite no longer registering participants, there are still 768 other trials currently recruiting patients."
Answered by AI
Has direct NMT been given the green light by the FDA?
"Direct NMT's safety received a score of 1 because there are minimal clinical data suggesting its efficacy and security."
Answered by AI
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