Phase 2 Obesity Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
For the mother:
- A planned caesarean delivery at 37 weeks of pregnancy or later
- Carrying a single baby, in good general health, and aged 18 or older
- Tested negative for infections that can be passed through bodily fluids, as part of standard early pregnancy care
- Tested negative for Group B strep bacteria between 35 and 37 weeks of pregnancy
- Vaginal pH of 4.5 or lower, which indicates a healthy balance of bacteria in the vagina
- No health complications for the mother or baby that would prevent the microbiome restoration procedure from being carried out
- Able to speak English or Spanish
- Tested negative for Gonorrhea, Chlamydia, Hepatitis B, Hepatitis C, Syphilis, and HIV at 35 weeks of pregnancy or later
- For women aged 18–29: a normal cervical screening (Pap) test within the past 3 years
- For women aged 30–65: a normal Pap test plus an HPV test within the past 5 years, or an approved HPV-only test within the past 5 years, or a normal Pap test alone within the past 3 years
- Tested negative for COVID-19 (SARS-CoV-2) on admission for delivery, as part of standard care at Inova Health System
For the baby:
- After birth, the baby requires no more than basic standard newborn care, such as gentle stimulation, suctioning, drying, or oxygen without breathing assistance
Who may not be able to join:
For the mother:
- Delivery planned at a hospital other than Inova Health System
- Caesarean delivery scheduled because of an active infection that would have prevented a vaginal birth, such as active genital herpes sores
- Waters (membranes) breaking before the scheduled caesarean delivery
- A diagnosis of bacterial vaginosis within the 30 days before the caesarean delivery
- A symptomatic urinary tract infection within the 30 days before the caesarean delivery
- Antibiotic use within the 30 days before the caesarean delivery, not counting antibiotics given as standard prevention during surgery
- Signs of a uterine infection (chorioamnionitis) on admission, such as fever or tenderness over the uterus
- Signs of a possible vaginal infection on admission for delivery, such as active genital herpes sores
- A personal history of genital herpes (HSV)
- A previous positive test for Group B strep
- A previous child diagnosed with Group B strep blood infection (sepsis)
- A pregnancy resulting from a donor egg or surrogacy arrangement
- A pre-existing diagnosis of Type 1 or Type 2 diabetes
- A history of genital HPV infection, a previous positive HPV test, or genital warts identified by a doctor
- A positive COVID-19 test within 30 days of delivery, or signs of possible COVID-19 infection on admission for delivery
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Suchitra Hourigan, MD, Chief, Clinical Microbiome Unit, NIAID, Pediatric Gastroenterologist, National Institute of Allergy and Infectious Diseases (NIAID), Inova Children's Hospital
Phone: 703-776-8489
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
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Trial details
Where this trial is recruiting
Primary endpoints
Adiposity
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.