Vaginal Seeding for Allergies and Asthma in C-section Infants

Not currently recruiting at 1 trial 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether transferring beneficial bacteria from a mother’s vaginal canal to babies born via C-section can reduce their risk of developing allergies and asthma. Researchers believe these bacteria play a crucial role in shaping a baby's immune system immediately after birth. Participants include pregnant women having a C-section, whose babies face a higher risk for allergies or asthma due to family history. Those planning a C-section, with a personal or paternal history of asthma, allergies, or similar conditions, might be suitable for this study. As an Early Phase 1 trial, this research focuses on understanding how this innovative treatment works in people, offering participants the chance to be among the first to receive it.

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.

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

Research suggests that vaginal seeding might safely introduce helpful bacteria to babies born via C-section. Studies indicate that this process could help restore the natural balance of bacteria in the body, which C-section delivery might disrupt. Maintaining this balance might reduce the risk of allergies and asthma as the child grows.

Reports show that vaginal seeding usually does not cause serious side effects. However, because this treatment is still new, researchers closely monitor its safety. So far, no clear reports have linked harmful effects directly to the treatment.

This trial is in its early stages, focusing on ensuring the treatment's safety for people. Although information on safety is limited, close monitoring remains a priority. Current evidence suggests that infants generally tolerate vaginal seeding well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about vaginal seeding for allergies and asthma because it introduces a novel approach to building an infant's immune system, especially for those born through C-section. Unlike typical treatments that manage symptoms of allergies and asthma with medications like antihistamines or inhalers, vaginal seeding involves transferring the mother's vaginal microbiota to the newborn, potentially establishing a healthier microbiome early in life. This method aims to mimic the natural exposure infants receive during vaginal birth, which is thought to play a role in immune system development. By focusing on prevention through microbiome modification, this approach could reduce the incidence of allergic and asthmatic conditions rather than just treating them after they occur.

What evidence suggests that vaginal seeding might be an effective treatment for allergies and asthma in C-section infants?

Research has shown that vaginal seeding might help restore natural bacteria for babies born by C-section. Some studies suggest that being born this way can increase the risk of allergies and asthma because the baby misses out on helpful bacteria from the mother's birth canal. In this trial, one group of infants born via C-section will receive vaginal seeding, which involves transferring these helpful bacteria to the baby, potentially reducing this risk. Another group will receive placebo seeding, using sterile gauze instead. Although current evidence indicates only small changes in the gut bacteria of C-section babies after vaginal seeding, researchers continue to study it as a promising way to support their immune system. However, the safety and effectiveness of this method are not yet fully confirmed, and more research is needed. ^{1 6 7 8 9}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: C-section -Vaginal seeding Experimental Treatment 3 Interventions

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 3 Interventions

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: Vaginal Delivery Active Control 1 Intervention

Pregnant women who undergo spontaneous vaginal delivery (of neonate).

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

PPD Development, LP

Industry Sponsor

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

Published Research Related to This Trial

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]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12195427/

Can Vaginal Seeding at Birth Improve Health Outcomes of ...

Vaginal seeding is hypothesized to partially restore the microbiome disrupted by C-section delivery, potentially reducing the risk of developing ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S0163445324002834

Impact of vaginal seeding on the gut microbiome of infants ...

Current evidence indicates modest changes in the gut microbiome of CS-born infants following VS. However, further clinical studies are necessary.

3.

withpower.com

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acog.org/news/news-releases/2017/10/vaginal-seeding-not-recommended-for-infants

Vaginal Seeding Not Recommended for Infants

There has been growing interest in vaginal seeding due to evidence that suggests the frequency of asthma, allergies and immune disorders in ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT03567707?term=FELIS%20CATUS%20MILK&viewType=Table&rank=1

Vaginal Microbiome Exposure and Immune Responses in ...

There is information that suggests C-section birth is associated with higher risk of certain diseases, including allergies and asthma. Some researchers think ...

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acog.org

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Vaginal Seeding

Cesarean delivery also was associated with subsequent diagnosis of asthma (OR, 1.24; 95% CI, 1.01–1.53); this association was gender specific, with a positive ...

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S2772829325001596

Exposure to Vaginal Microbiome in Cesarean-Delivered ...

This pilot study will provide important data on the effects of vaginal seeding on allergen sensitization, the microbiome, and the development of ...

8.

jaci-global.org

jaci-global.org/article/S2772-8293(25)00159-6/fulltext

Exposure to vaginal microbiome in cesarean-delivered ...

This pilot study will provide important data on the effects of vaginal seeding on allergen sensitization, the microbiome, and the development of immune ...

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3110651/

Cesarean versus Vaginal Delivery: Long term infant ...

Available epidemiological data show that atopic diseases appear more often in infants after cesarean delivery than after vaginal delivery.- The composition of ...