Vaginal Seeding for Allergies and Asthma in C-section Infants

Recruiting in New York (>99 mi)

+1 other location

Age: 18 - 65

Sex: Female

Trial Phase: Phase < 1

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Must not be taking: Induction agents, Antibiotics

Disqualifiers: Diabetes, IBD, Hepatitis, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: Immediate post-birth

114 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to assess at how differences in the microbiome (naturally occurring bacteria) of a baby may protect, or put a baby at risk, for allergic problems. The microbiome refers to the thousands of bacteria and molds that live in and on our bodies. The microbiome plays an important role in our health. Differences in the microbiome can affect our immune system in ways that might make some people more likely to get allergies and asthma. Early life events and exposures are very important for establishing the human microbiome. The newborn baby's microbiome changes very quickly during the first weeks and months of life. There is information that suggests C-section birth is associated with higher risk of certain diseases, including allergies and asthma. Some researchers think one reason for this is that passing through the mother's vaginal canal during birth exposes the baby to bacteria that promote healthy immune system development, something that C-section babies don't get. Transferring these potentially beneficial vaginal bacteria to C-section babies may help prevent some diseases later.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using investigational drugs during the third trimester of pregnancy, you may not be eligible to participate.

What data supports the effectiveness of the treatment 'Vaginal Seeding for Allergies and Asthma in C-section Infants'?

Preliminary evidence suggests that vaginal seeding can partially restore the microbiota (community of microorganisms) in C-section-born infants to resemble those born vaginally, which may help in normalizing immune development. However, there is currently insufficient evidence to confirm the health benefits of this treatment, and more research is needed. ^{1 2 3 4 5}

Is vaginal seeding safe for C-section infants?

Currently, there is not enough evidence to confirm the safety of vaginal seeding for C-section infants, and it should only be done as part of approved research studies until more data is available. ^{1 2 3 4 6}

How does the treatment of vaginal seeding for allergies and asthma in C-section infants differ from other treatments?

Vaginal seeding is unique because it involves swabbing C-section infants with the mother's vaginal fluids to transfer beneficial bacteria, aiming to mimic the natural exposure that occurs during vaginal birth. This approach is novel as it seeks to restore the infant's gut microbiome, potentially reducing the risk of allergies and asthma, unlike traditional treatments that do not address microbiome differences. ^{1 3 6 7 8}

Research Team

Hugh A. Sampson, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Jose C. Clemente, PhD

Principal Investigator

Icahn Institute for Genomics & Multiscale Biology

Eligibility Criteria

This trial is for pregnant women planning a C-section who understand the study and consent to participate. Their babies must have a relative with allergies or asthma, but can't join if there's labor before the C-section, water breaks early, high vaginal pH, or certain infections like HIV or hepatitis. Moms with serious health issues or on certain medications are also excluded.

Inclusion Criteria

Pregnant women with singleton pregnancies with a non-anomalous, appropriately-grown fetus

Pregnant woman must be able to understand and provide informed consent

Atopic disease (asthma, allergic rhinoconjunctivitis, or atopic dermatitis) or food allergy in a first-degree relative of the infant to-be-delivered (for exception, see exclusion criteria*)

Exclusion Criteria

My baby needed extra help beyond normal care after birth.

I do not have an active STI, yeast infection, or vaginosis on the day of delivery.

Infants delivered prior to 37 weeks of gestation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Infants undergo either vaginal seeding or placebo seeding immediately after birth, followed by standard care

Immediate post-birth

1 visit (in-person)

Follow-up

Participants are monitored for microbiome development and allergen sensitization

52 weeks

Weekly at-home collections for 4 weeks, visits at weeks 8, 13, 26, 39, and 52

Long-term monitoring

Continued assessment of allergen sensitization and immune response at 12 months

12 months

Treatment Details

Interventions

• C-section - Placebo Seeding
• C-section -Vaginal seeding
• standard care

Trial Overview The study tests whether exposing C-section newborns to their mother's vaginal bacteria (vaginal seeding) might reduce allergy and asthma risk compared to placebo seeding or standard care. It explores how this exposure could influence the baby’s immune system by comparing these three approaches.

Participant Groups

Group I: C-section -Vaginal seeding Experimental Treatment 1 Intervention

Pregnant women who undergo C-section and (neonate) vaginal seeding. Infants that are scheduled to be born in a hospital by standard C-section procedure (e.g., elective, unlabored C-section) will be wiped with gauze containing their mother's vaginal microbiota just after delivery.

Group II: C-section - Placebo Seeding Experimental Treatment 1 Intervention

Pregnant women who undergo C-section and (neonate) placebo seeding. Infants that are scheduled to be born in a hospital by standard C-section procedure (e.g., elective, unlabored C-section) will be wiped with sterile gauze (placebo).

Group III: standard care Active Control 1 Intervention

Pregnant women who undergo spontaneous vaginal delivery (of neonate) . Pregnant women who undergo spontaneous vaginal delivery and (neonate) receives standard care.

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

PPD DEVELOPMENT, LP

Industry Sponsor

Trials

167

Recruited

38,000+

David Simmons

PPD DEVELOPMENT, LP

Chief Executive Officer since 2012

BSc in Applied Science from Georgia Institute of Technology

Martina Flammer

PPD DEVELOPMENT, LP

Chief Medical Officer since 2024

MD

Immune Tolerance Network (ITN)

Collaborator

Trials

68

Recruited

7,900+

Rho Federal Systems Division, Inc.

Industry Sponsor

Trials

44

Recruited

15,000+

PPD

Industry Sponsor

Trials

162

Recruited

36,600+

Dr. Austin Smith

PPD

Chief Medical Officer since 2020

Doctor of Medicine from the Royal College of Surgeons in Ireland

David Simmons

PPD

Chief Executive Officer since 2012

Bachelor’s degree in Applied Mathematics and Industrial Management from Carnegie Mellon University

Findings from Research

Children born via Cesarean section may face higher risks for health issues like allergies, asthma, and obesity, leading to interest in vaginal seeding as a potential solution.

Vaginal seeding aims to transfer the mother's vaginal microbiome to C-section infants, showing some promise in restoring microbial exposure, but there is currently insufficient evidence to confirm its health benefits, with ongoing studies needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bacterial Baptism: Scientific, Medical, and Regulatory Issues Raised by Vaginal Seeding of C-Section-Born Babies. Mueller, NT., Hourigan, SK., Hoffmann, DE., et al.[2021]

Vaginal seeding is a practice aimed at transferring maternal vaginal bacteria to newborns to promote healthy gut colonization and potentially reduce the risk of asthma and immune disorders, especially in infants born via cesarean delivery.

Currently, vaginal seeding should only be conducted within approved research protocols, as there is insufficient data on its safety and efficacy for widespread clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Committee Opinion No. 725: Vaginal Seeding. [2022]

Vaginal seeding is a practice aimed at transferring maternal vaginal bacteria to newborns to promote healthy gut colonization and potentially reduce the risk of asthma and immune disorders, especially in infants born via cesarean delivery.

Currently, vaginal seeding should only be conducted within approved research protocols, as there is insufficient data on its safety and efficacy for widespread clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Committee Opinion No. 725 Summary: Vaginal Seeding. [2018]

A study involving 15 pregnant women in interviews and 264 women in an online questionnaire revealed that many view vaginal seeding positively, believing it could replicate natural birth processes and potentially benefit the infant gut microbiome.

If proven safe and effective, vaginal seeding could serve as a non-stigmatizing method to help prevent early childhood obesity in babies born via caesarean section, highlighting the need for maternity caregivers to stay informed about this practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The views of pregnant women in New Zealand on vaginal seeding: a mixed-methods study. Butler, ÉM., Reynolds, AJ., Derraik, JGB., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Bacterial Baptism: Scientific, Medical, and Regulatory Issues Raised by Vaginal Seeding of C-Section-Born Babies. [2021]

2. 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]

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

Maternal bacteria to correct abnormal gut microbiota in babies born by C-section. [2022]

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

Can maternal-child microbial seeding interventions improve the health of infants delivered by Cesarean section? [2022]

5. England pubmed.ncbi.nlm.nih.gov

Reintroducing B. infantis to the cesarean-born neonate: an ecologically sound alternative to "vaginal seeding". [2022]

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

Committee Opinion No. 725: Vaginal Seeding. [2022]

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

Committee Opinion No. 725 Summary: Vaginal Seeding. [2018]

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

The views of pregnant women in New Zealand on vaginal seeding: a mixed-methods study. [2021]