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Probiotic

Vaginal Seeding for Cesarean-Delivered Infants

Phase 1 & 2
Recruiting
Led By Suchitra Hourigan, MD
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Must not have
Mother: Maternal history of documented genital HPV infection, positive HPV testing or genital warts on physician examination
Mother: Symptoms on admission suggesting Chorioamnionitis, e.g. maternal fever, fundal tenderness
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years

Summary

This trial will test whether or not exposing infants to their mother's vaginal flora via 'vaginal seeding' has any health benefits. Infants will be followed for three years to see if there are any differences in microbiome development, immune development, metabolism, or adverse events.

Who is the study for?
This trial is for healthy English or Spanish-speaking women aged 18+ scheduled for a Cesarean delivery at ≥37 weeks with a single fetus and normal vaginal flora. They must test negative for various infections including STIs, Group B strep, and COVID-19 close to the time of delivery. Women can't join if they have certain infections, history of genital herpes or HPV, diabetes, or are on recent antibiotics.
What is being tested?
The study tests whether exposing Cesarean-delivered babies to their mother's vaginal bacteria (vaginal seeding) affects their health outcomes over three years compared to those who don't get this exposure (sham). It looks at microbiome development, immune response, metabolic effects, and any adverse events.
What are the potential side effects?
Potential side effects aren't specified but may include risks associated with improper transfer of maternal bacteria such as infection. The long-term impact on children's health due to altered microbiome development will be closely monitored.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My mother had a confirmed genital HPV infection or genital warts.
Select...
I had symptoms like fever or belly pain suggesting an infection in the womb when admitted.
Select...
I had symptoms of a vaginal infection when I was admitted for delivery.
Select...
I have tested positive for Group B strep infection in the past.
Select...
I have a history of genital herpes.
Select...
I have a history of Type I or Type II Diabetes.
Select...
I have a child who was diagnosed with Group B strep sepsis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adiposity
Secondary study objectives
Adverse events
Immune and inflammatory regulation
Intestinal microbiota

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Receives Vaginal SeedingActive Control1 Intervention
Group II: No Vaginal SeedingPlacebo Group1 Intervention

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,322 Previous Clinical Trials
5,364,138 Total Patients Enrolled
Inova Health Care ServicesOTHER
73 Previous Clinical Trials
21,879 Total Patients Enrolled
Rutgers UniversityOTHER
118 Previous Clinical Trials
2,804,714 Total Patients Enrolled

Media Library

Vaginal Seeding (Probiotic) Clinical Trial Eligibility Overview. Trial Name: NCT03298334 — Phase 1 & 2
Cesarean Delivery Research Study Groups: No Vaginal Seeding, Receives Vaginal Seeding
Cesarean Delivery Clinical Trial 2023: Vaginal Seeding Highlights & Side Effects. Trial Name: NCT03298334 — Phase 1 & 2
Vaginal Seeding (Probiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03298334 — Phase 1 & 2
~160 spots leftby Apr 2027
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