Vaginal microbiome exposure for newborns delivered by C-section
Vaginal Microbiome Seeding and Health Outcomes in Cesarean-delivered Neonates: a Randomized Controlled Trial
This study is testing if exposing newborns delivered by C-section to their mother’s vaginal bacteria can improve their health and development over the first three years of life.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 0 Days to 50 Years |
| Sex | All |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) NIH |
| Locations | 1 site (Falls Church, Virginia) |
| Trial ID | NCT03298334 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of vaginal microbiome seeding on health outcomes in newborns delivered via scheduled Cesarean section. Infants will be randomly assigned to receive either exposure to their mother's vaginal flora or a sham treatment at birth. The study aims to assess the impact of this intervention on the development of the gut microbiome, immune function, and metabolic outcomes over a three-year period. The trial is divided into two phases, with the first phase focusing on microbiota composition and the second phase evaluating body mass index and immune-mediated outcomes in a larger cohort.
Who should consider this trial
Good fit: Ideal candidates include mothers scheduled for Cesarean delivery at 37 weeks or later, in good health, and with a Lactobacillus-dominated vaginal microbiota.
Not a fit: Patients who may not benefit include those with complications during pregnancy or those who do not meet the strict eligibility criteria for maternal health and microbiota status.
Why it matters
Potential benefit: If successful, this approach could reduce the risk of obesity and immune disorders in Cesarean-delivered infants by restoring beneficial maternal microbes.
How similar studies have performed: Previous pilot studies have shown promising results in normalizing microbiota through vaginal seeding, suggesting potential for success in this larger trial.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Falls Church, Virginia
- Inova Health System — Falls Church, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Suchitra Hourigan, MD, Chief, Clinical Microbiome Unit, NIAID, Pediatric Gastroenterologist — National Institute of Allergy and Infectious Diseases (NIAID), Inova Children's Hospital
- Study coordinator: Suchitra Hourigan, MD
- Email: suchitra.hourigan@inova.org, suchitra.hourigan@nih.gov
- Phone: 703-776-8489
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.