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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:

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My mother had a confirmed genital HPV infection or genital warts.

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I had symptoms like fever or belly pain suggesting an infection in the womb when admitted.

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I had symptoms of a vaginal infection when I was admitted for delivery.

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I have tested positive for Group B strep infection in the past.

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I have a history of genital herpes.

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I have a history of Type I or Type II Diabetes.

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I have a child who was diagnosed with Group B strep sepsis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

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

0 / 7Eligibility criteria met

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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

3,336 Previous Clinical Trials

5,382,234 Total Patients Enrolled

Inova Health Care ServicesOTHER

73 Previous Clinical Trials

21,812 Total Patients Enrolled

Rutgers UniversityOTHER

121 Previous Clinical Trials

2,808,754 Total Patients Enrolled

Johns Hopkins UniversityOTHER

2,339 Previous Clinical Trials

14,881,073 Total Patients Enrolled

Suchitra Hourigan, MDPrincipal InvestigatorInova Children's Hospital

Lawrence Appel, MD, MPHPrincipal InvestigatorJohns Hopkins University

2 Previous Clinical Trials

285 Total Patients Enrolled

Suchitra Hourigan, MD, Chief, Clinical Microbiome Unit, NIAID, Pediatric Gastroenterologist3.04 ReviewsPrincipal Investigator - National Institute of Allergy and Infectious Diseases (NIAID), Inova Children's Hospital

Inova Health Care Services

5Patient Review

We adore Doctor Hourigan! She is an excellent Pediatric GI who is both patient and knowledgeable. We feel so lucky to have her as our physician!

Maria Gloria Dominguez Bello, PhDPrincipal InvestigatorRutgers University

Noel Mueller, PhDPrincipal InvestigatorJohns Hopkins University