Vaginal Seeding for Allergies and Asthma in C-section Infants
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.12345Why 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.16789
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Infants undergo either vaginal seeding or placebo seeding immediately after birth, followed by standard care
Follow-up
Participants are monitored for microbiome development and allergen sensitization
Long-term monitoring
Continued assessment of allergen sensitization and immune response at 12 months
What Are the Treatments Tested in This Trial?
Interventions
- C-section - Placebo Seeding
- C-section -Vaginal seeding
- standard care
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
PPD DEVELOPMENT, LP
Industry Sponsor
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
Rho Federal Systems Division, Inc.
Industry Sponsor
PPD
Industry Sponsor
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