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

Phase 1

Recruiting

• Conditions: Cesarean Delivery Affecting Newborn; Intestinal Microbiome; Gastrointestinal Microbiome; Host Microbial Interactions; Obesity, Childhood; Microbiota
• Interventions: Other: No Vaginal Seeding; Biological: Vaginal Seeding

• Registration Number: NCT03298334
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief 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.

Detailed Description

Cesarean section (CS) delivery is a common surgical procedure intended to increase the chances of successful delivery and to protect the health of the mother and baby. Yet this intervention is overused and has been associated with higher risk of immune and metabolic disorders in the offspring. It is hypothesized that these associations are due to CS-delivered newborns not receiving the full inoculum of maternal microbes at birth.

While restoring labor is not possible, restoring the microbes that colonize infants during birth through exposure to vaginal flora, is feasible, and has been shown in a small pilot study, to normalize the microbiota of the intestine, skin and mouth during the first month of life.

The investigators hypothesize that the restoration of the vaginal microbiota to the infant at birth will restore the infant microbiome and decrease the risk of obesity and other immune-mediated diseases linked with CS. The investigators aim to test this hypothesis in a randomized controlled trial by first examining the effect of vaginal seeding, in CS-delivered newborns, on the gut microbiota composition, structure and function (Phase I of study; first 50 infants) and then on the BMI z score and other immune-mediated outcomes (Phase II of study; 600 infants).

Methods: CS-delivered neonates will be randomized to either an experimental arm with exposure to the maternal vaginal microbiota at birth, or a control arm with no exposure. Feces, skin, saliva, breast milk, and vaginal swabs will be collected for microbiome analysis. The investigators will obtain clinical information from in-person visits, surveys and the electronic health record.

Implications: this randomized controlled clinical study will provide evidence of whether the "vaginal seeding" procedure can safely transfer microbes from mom-to-baby, and whether these microbes are beneficial for the metabolic and immune health of the child.

Study Timeline

• Study First Submitted: 2017-09-27
• Study First Submitted QC: 2017-09-27
• Study First Posted: 2017-10-02
• Study Start: 2018-07-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-18
• Primary Completion: 2027-04
• Study Completion: 2029-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Vaginal Seeding	No Vaginal Seeding	-
Receives Vaginal Seeding	Vaginal Seeding	-

Primary Outcome Measures

Name	Time	Method
Adiposity	2 years	E.g. Body mass index z-score

Secondary Outcome Measures

Name	Time	Method
Immune and inflammatory regulation	3 years	E.g. Monitoring for immune and inflammatory mediated conditions
Intestinal microbiota	3 years	Intestinal microbiota development over the first three years of life
Adverse events	3 years	Monitoring for adverse events

Trial Locations

Locations (1)

Inova Health System; 🇺🇸 Falls Church, Virginia, United States