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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adiposity
Secondary outcome measures
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
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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
3,270 Previous Clinical Trials
5,484,637 Total Patients Enrolled
Inova Health Care ServicesOTHER
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Rutgers UniversityOTHER
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Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My mother had a confirmed genital HPV infection or genital warts.My newborn needed standard help after birth or can't undergo the full VMT procedure due to health reasons.I am pregnant with one baby, healthy, and over 18.I speak English or Spanish.I am a woman aged 18-29 and had a normal Pap test in the last 3 years.I had bacterial vaginosis within a month before my C-section.I have not taken antibiotics in the last 30 days since my cesarean delivery, except for those given to me at the time of surgery.I had symptoms like fever or belly pain suggesting an infection in the womb when admitted.I had symptoms of a vaginal infection when I was admitted for delivery.I have tested positive for Group B strep infection in the past.I am a woman aged 30-65 with recent normal cervical cancer screenings.I have a history of genital herpes.I have a history of Type I or Type II Diabetes.I have a child who was diagnosed with Group B strep sepsis.
Research Study Groups:
This trial has the following groups:- Group 1: No Vaginal Seeding
- Group 2: Receives Vaginal Seeding
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research project allow octogenarians to participate?
"The age range for people eligible to participate in this clinical trial is 0 days to 50 years old."
Answered by AI
How many total patients are being asked to participate in this trial?
"That is correct. The online registry shows that the clinical trial, which was first advertised on July 1st 2018 and had its last update on June 15th 2022, is still recruiting patients. So far, 600 people have been accepted at the one location."
Answered by AI
Are there any current vacancies for people who want to participate in this clinical trial?
"That is correct. The most recent update on clinicaltrials.gov indicates that this study was last updated on June 15th, 2022 and that they are still actively recruiting the 600 participants from 1 location."
Answered by AI
Would I be able to help out with this research project?
"Eligible patients for this clinical trial must have host microbial interactions and be between 0 days old to 50 years old. Around 600 people are needed for the study."
Answered by AI
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