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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to prevent infections in newborns through a nasal microbiota transplant. Researchers aim to determine if transferring healthy nasal bacteria from a parent to their baby can establish a strong, healthy nasal environment in the newborn. The trial includes different groups: one where newborns receive nasal bacteria directly from a parent, another where it's mixed in a liquid, and a placebo group that receives only saline. Families with newborns expected to stay in the NICU for more than a week and who lack Staphylococcus aureus (a common bacteria) in their noses may be suitable for this study. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that similar procedures, like Fecal Microbiota Transplants (FMT), are well-tolerated. Although specific safety data for Nasal Microbiota Transplants (NMT) is not yet available, the procedures share similarities. The aim is to transfer healthy bacteria from a parent to a baby to support a healthy nasal environment.

This is a Phase 1 trial, the first step in assessing the treatment's safety. This phase primarily focuses on safety and potential side effects. If the treatment were unsafe, it would not have progressed to this stage. However, due to the early stage of research, human data remains limited.

Overall, while direct safety data is limited, similar treatments have been conducted safely. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Nasal Microbiota Transplant (NMT) because it offers a novel way to prevent infections in newborns by leveraging the beneficial bacteria from a parent's nose. Unlike traditional treatments that might rely on antibiotics to manage infections after they occur, NMT aims to proactively protect infants by enhancing their nasal microbiome right from birth. This method is unique because it directly transfers beneficial microbes, either using a swab directly or indirectly via a saline solution, potentially reducing the need for antibiotics and their associated risks. By boosting the infant's natural defenses, NMT could offer a more natural and potentially safer way to prevent newborn infections.

What evidence suggests that this trial's treatments could be effective for preventing newborn infections?

Research has shown that a newborn's nasal microbiota, the collection of microorganisms in the nose, is less varied than that of their parent. This variety is crucial for protecting babies from infections. The trial will compare different methods of Nasal Microbiota Transplant (NMT) with a placebo. Studies have found that transferring nasal microbiota from a parent to their baby can introduce beneficial microbes into the baby's nose. This process may help create a healthier and more diverse microbial mix. Early findings suggest that a richer nasal microbiome could serve as a strong first line of defense against illnesses. ^{1 2 3 6 7}

Who Is on the Research Team?

Aaron Milstone

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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

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

Parent/adult provider is able to provide informed consent

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)

Neonate has had a prior clinical or surveillance culture grow S. aureus

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06283355?cond=Parents+and+Children&aggFilters=status%3Arec

Comparing Single Versus Repeat NMT on the Diversity of ... This study aims to determine whether a parent-to-child nasal microbiota transplant (NMT) can seed and engraft parental organisms into the ...

2. withpower.com withpower.com/trial/phase-1-staphylococcus-aureus-4-2024-a1eb9

Nasal Bacteria Transfer for Neonatal Infections This study aims to determine whether a parent-to-child nasal microbiota transplant (NMT) can seed and engraft parental organisms into the neonatal microbiome ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11561572/

Association of Neonatal and Maternal Nasal Microbiome ... As hypothesized, our data demonstrate that a neonate's nasal microbiota shortly after birth was less diverse than the mother's nasal microbiome. Similar to ...

4. clinicaltrial.be clinicaltrial.be/en/details/426962?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Comparing Single Versus Repeat NMT on the Diversity of ... This parent-to-child NMT study will test the effect of an anterior nares, or nasal, microbiota transplant (NMT) on seeding, engraftment, and diversity of the ...

5. biocodexmicrobiotainstitute.com biocodexmicrobiotainstitute.com/en/nasal-microbiota-your-babys-first-line-defense

The nasal microbiota: your baby's first line of defense How do viruses make babies sick? New research reveals they disrupt the nasal microbiota, the frontline of an infant's respiratory immune ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05695196/feasibility-and-safety-study-of-parent-to-child-nasal-microbiota-transplant

Feasibility and Safety Study of Parent-to-Child Nasal ... This feasibility and safety pilot study looks to determine whether transferring a parents healthy, diverse nasal microbiota to the participant's infant(s) will ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2405844024150785

Microbiota transplantation 5) [25,93]. Research has demonstrated that transplanting nasal microbiota from healthy individuals to patients can alleviate the symptoms of ...