Vaginal Microbiome Seeding and Health Outcomes in Cesarean-delivered Neonates.

Recruiting Phase 1 Phase 2 Interventional Study
Cesarean Delivery Affecting Newborn Obesity, Childhood Intestinal Microbiome Microbiota Host Microbial Interactions Gastrointestinal Microbiome
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.
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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
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About This Trial

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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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…
Contacts

Suchitra Hourigan, MD

703-776-8489

suchitra.hourigan@inova.org, suchitra.hourigan@nih.gov

CONTACT

Shira Levy

703-776-8489

shira.levy@inova.org

CONTACT