Vaginal Seeding for Allergies and Asthma in C-section Infants

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

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

No Placebo Group

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.

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

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Treatment Details

Interventions

C-section - Placebo Seeding (Drug)
C-section -Vaginal seeding (Procedure)
standard care ()

Trial OverviewThe 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

3Treatment groups

Experimental Treatment

Active Control

Group I: C-section -Vaginal seedingExperimental Treatment1 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 SeedingExperimental Treatment1 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 careActive Control1 Intervention

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