RecruitingPhase 1Phase 2NCT03298334

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

Vaginal Microbiome Seeding and Health Outcomes in Cesarean-delivered Neonates: a Randomized Controlled Trial

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Enrollment

600 participants

Start Date

Jul 1, 2018

Study Type

INTERVENTIONAL

Conditions

Intestinal microbiome Microbiota Gastrointestinal Microbiome Obesity, Childhood Cesarean Delivery Affecting Newborn Host Microbial Interactions

Summary

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.

Eligibility

Min Age: 0 DaysMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying No Vaginal Seeding and a biological treatment called Vaginal Seeding for people with cesarean delivery affecting newborn, gastrointestinal microbiome, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 0 Days to 50 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALVaginal Seeding

A gauze containing the Mother's vaginal flora will be swabbed over the face and body of the neonate shortly after cesarean delivery.

OTHERNo Vaginal Seeding

A gauze carrying sterile saline will be swabbed over the face and body of the neonate shortly after cesarean delivery.

Locations(1)

Inova Health System

Falls Church, Virginia, United States

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NCT03298334

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