No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
0 Days – 50
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Prevention
Participants needed
600 (estimated)
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) · NIH
Who this trial is looking for
This trial is looking for mothers scheduled for a C-section who are interested in helping their babies develop healthy gut bacteria. Participants will have their infants exposed to the mother's vaginal bacteria after birth, and the babies will be followed for three years to track their health.
Are You a Good Fit for This Trial?
Rules you outDiabetesGenital HPV infectionHistory of Group B strep infection
You may be able to join if
I am scheduled for a C-section at 37 weeks or later.
I am in good general health.
I am 18 years or older.
I speak English or Spanish.
I tested negative for certain infections in early pregnancy.
I tested negative for Group B strep during pregnancy.
I do not have any complications that would prevent the procedure.
My vaginal health is good based on testing.
You may not be able to join if
I am delivering at a hospital that is not Inova Health System.
I have an active infection that could complicate the delivery.
I have had a rupture of membranes before my C-section.
I have bacterial vaginosis or a urinary tract infection within the past 30 days.
I have taken antibiotics within the past 30 days, except for surgery prep.
I have experienced symptoms of infection during my admission.
I have a history of genital herpes.
I have tested positive for SARS-CoV-2 within the past 30 days.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Neonates delivered by scheduled Cesarean Section will be randomized to receive vaginal seeding (exposing the infant to Mother's vaginal flora) or sham. Infants will be followed for three years to examine health outcomes including microbiome development, immune development, metabolic outcomes, and any adverse events.
Trial Locations
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Facility
City
State
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Status
Eligibility Criteria
Inclusion Criteria for Mother:
* Scheduled for cesarean delivery at ≥ 37 weeks
* Pregnant with single fetus, in good general health, age 18 years or older
* Negative maternal testing for infections transmitted through vaginal and/or other body fluids performed as standard of care tests in early pre…
Inclusion Criteria for Mother:
* Scheduled for cesarean delivery at ≥ 37 weeks
* Pregnant with single fetus, in good general health, age 18 years or older
* Negative maternal testing for infections transmitted through vaginal and/or other body fluids performed as standard of care tests in early pregnancy
* Negative testing for Group B strep at 35-37 weeks gestation
* Vaginal pH ≤ 4.5 indicative of Lactobacillus-dominated vaginal microbiota
* No maternal or fetal complications that may inhibit the ability to perform microbiome restoration per protocol
* English or Spanish speaking
* Negative maternal testing for Gonorrhea, Chlamydia, Hepatitis B, Hepatitis C, Syphilis, and HIV at 35 weeks gestation or later
* Women aged 18-29 years must have a normal Pap test within 3 years
* Women aged 30-65 years must have a normal Pap test and an HPV test (co-testing) within 5 years or FDA-approved primary hrHPV testing alone within 5 years or a normal Pap test alone within 3 years
* Negative maternal testing for SARS-CoV-2 for the delivery admission performed as standard of care test at the Inova Health System.
Inclusion Criteria for Infant:
* Infant condition after delivery requires no more than standard neonatal resuscitation\* or is otherwise medically unable to receive the full VMT procedure
\[\*\] Standard neonatal resuscitation may include: tactile stimulation, bulb suction, oxygen without positive pressure, or drying
Exclusion Criteria for Mother:
* Delivery at a hospital other than Inova Health System
* Cesarean delivery scheduled for active infection that would have interfered with vaginal delivery such as genital herpetic lesions
* Rupture of membranes prior to scheduled cesarean delivery
* Bacterial vaginosis within 30 days of cesarean delivery
* Symptomatic urinary tract infection within 30 days of cesarean delivery
* Antibiotic therapy within 30 days of cesarean delivery (exclusive of medication use for prophylaxis at the time of surgery)
* Symptoms on admission suggesting Chorioamnionitis, e.g. maternal fever, fundal tenderness
* Symptoms on delivery admission of possible vaginal infection such as genital herpetic lesions
* History of genital HSV
* History positive testing for Group B strep infection
* History of a child with a diagnosis of Group B strep sepsis
* Pregnancy a result of donor egg or surrogacy
* Preexisting history of Type I or Type II Diabetes
* Maternal history of documented genital HPV infection, positive HPV testing or genital warts on physician examination
* Positive maternal testing for SARS-CoV-2 within 30 days of delivery or symptoms on admission suggesting potential Covid-19 infection
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