Nasal Microbiota Transplant for Preventing Newborn Infections

(ParentsTREAT Trial)

Overseen By Danielle Koontz

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Johns Hopkins University

Disqualifiers: S. aureus colonization, Immunodeficiency, Respiratory illness, others

Compensation: Varies

Number of Visits: 6

Duration: 1 day

34 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing if transferring healthy bacteria from a parent's nose to their newborn's nose can help protect the baby from harmful bacteria. The study focuses on newborns at Johns Hopkins Hospital. By creating a healthy bacterial environment in the baby's nose, the researchers hope to reduce the risk of infections.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the Nasal Microbiota Transplant treatment for preventing newborn infections?

Research shows that early establishment of nasal microbiota can influence immune responses and reduce susceptibility to respiratory disorders in children. Additionally, studies on similar treatments, like vaginal seeding, suggest that restoring microbiota in newborns can improve microbial colonization, which is important for immune health. ^{1 2 3 4 5}

How does the Nasal Microbiota Transplant treatment differ from other treatments for preventing newborn infections?

The Nasal Microbiota Transplant is unique because it involves transferring beneficial bacteria directly to the nose to help prevent infections, unlike traditional treatments that might use antibiotics or vaccines. This approach aims to establish a healthy nasal microbiome early in life, which can influence immune responses and reduce susceptibility to infections. ^{1 4 6 7 8}

Research Team

Aaron Milstone

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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.

Inclusion Criteria

Parent/adult provider is able to provide informed consent

At least one parent/adult provider not colonized with S. aureus (as determined by baseline screening)

Neonate has anticipated NICU length of stay > 7 days

Exclusion Criteria

Parent/adult provider tests positive on baseline screening test for S. aureus nasal colonization

Neonate cannot have nasal swabs collected (due to anatomic or other clinical intervention, including nasal packing)

I am experiencing symptoms like a runny nose, congestion, fever, or cough.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Eligible neonates undergo a nasal microbiome transplant

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

4 visits (in-person)

Treatment Details

Interventions

• Nasal Microbiota Transplant
• Placebo

Trial Overview 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.

Participant Groups

Group I: indirect NMT Experimental Treatment 1 Intervention

swab parent nares, inoculate swab into saline, instill liquid into neonate nares

Group II: direct NMT Experimental Treatment 1 Intervention

swab parent nares then insert swab directly into neonate nares

Group III: placebo Placebo Group 1 Intervention

instill sterile saline into neonate nares

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Findings from Research

Hospitalized neonates who did not acquire Staphylococcus aureus nasal colonization had a higher abundance of beneficial bacterial species that can help prevent S. aureus colonization, suggesting a protective role of the nasal microbiota.

After treatment with intranasal mupirocin, cases showed an increase in Rothia mucilaginosa, indicating that certain bacteria may thrive post-treatment, which could influence future strategies for preventing S. aureus infections in vulnerable infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Association Between the Developing Nasal Microbiota of Hospitalized Neonates and Staphylococcus aureus Colonization. Khamash, DF., Mongodin, EF., White, JR., et al.[2022]

The study analyzed the nasal microbiota of 122 infants over 18 months, revealing that infants with rhinitis showed a decrease in bacterial diversity compared to healthy controls, suggesting a potential link between microbiome development and respiratory issues.

Specific bacterial families, such as Oxalobacteraceae and Aerococcaceae, were more abundant in infants with rhinitis and wheeze, while healthy infants had higher levels of Corynebacteriaceae, indicating that the composition of the nasal microbiome may influence susceptibility to respiratory disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Establishment of the nasal microbiota in the first 18 months of life: Correlation with early-onset rhinitis and wheezing. Ta, LDH., Yap, GC., Tay, CJX., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Populating preterm infants with probiotics. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The Association Between the Developing Nasal Microbiota of Hospitalized Neonates and Staphylococcus aureus Colonization. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Mapping and comparing bacterial microbiota in the sinonasal cavity of healthy, allergic rhinitis, and chronic rhinosinusitis subjects. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Establishment of the nasal microbiota in the first 18 months of life: Correlation with early-onset rhinitis and wheezing. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Maternal Bacterial Engraftment in Multiple Body Sites of Cesarean Section Born Neonates after Vaginal Seeding-a Randomized Controlled Trial. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Nasopharyngeal microbiome in premature infants and stability during rhinovirus infection. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Oral Bacteria Combined with an Intranasal Vaccine Protect from Influenza A Virus and SARS-CoV-2 Infection. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Bacterial community structure and effects of picornavirus infection on the anterior nares microbiome in early childhood. [2020]