Vaginal Microbiome Seeding and Health Outcomes in Cesarean-delivered Neonates.
Recruiting now · Phase 1/Phase 2
Conditions studied: Cesarean Delivery Affecting Newborn, Obesity, Childhood, Intestinal Microbiome, Microbiota, Host Microbial Interactions, Gastrointestinal Microbiome
In brief
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.
Key facts
- Study ID
- NCT03298334
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 600
- Starts
- 2018-07-01
- Expected to finish
- 2029-04-01
- Last updated by the study team
- 2025-06-08
Who can join
Age: any, up to 50. Sex: any. Healthy volunteers: accepted.
Where it is running
- Inova Health System — Falls Church, Virginia, United States (enrolling)
Full record on ClinicalTrials.gov
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