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Microbiota Transplant

Single NMT for Staph Infection

Phase 1

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 2, 4, 7, 10, 14 days post-intervention

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

Select...

My baby was born at or after 25 weeks of pregnancy.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 2, 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

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.

0 / 1Eligibility criteria met

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

2,260 Previous Clinical Trials

14,820,605 Total Patients Enrolled

Aaron Milstone, MDPrincipal InvestigatorJohns Hopkins University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals above the age of 70 being considered for participation in this trial?

"The recruitment for this research study targets individuals above infancy and under the age of 60 years."

Answered by AI

Is the recruitment phase of this clinical trial still ongoing?

"The trial listed on clinicaltrials.gov, uploaded on May 15th, 2024 and last revised on February 21st of the same year, is not actively seeking participants. However, it's worth noting that there are currently 749 alternative studies open for patient enrollment."

Answered by AI

Has the FDA officially approved Single NMT for medical use?

"According to our team at Power, the safety of Single NMT is rated as 1 on a scale of 3 due to this being a Phase 1 trial with minimal evidence supporting both its safety and effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparing Single Versus Repeat NMT on the Diversity of the Neonatal Nasal Microbiome

2024. "Comparing Single Versus Repeat NMT on the Diversity of the Neonatal Nasal Microbiome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06283355.

All > Microbiome