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

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ClinicalTrials.gov Identifier: NCT03298334
Recruitment Status : Recruiting
First Posted : October 2, 2017
Last Update Posted : August 8, 2018
Sponsor:
Collaborators:
Johns Hopkins University
Rutgers University
Information provided by (Responsible Party):
Suchitra Hourigan, Inova Health Care Services

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.

Condition or disease Intervention/treatment Phase
Cesarean Delivery Affecting Newborn Obesity, Childhood Intestinal Microbiome Biological: Vaginal Seeding Other: No Vaginal Seeding Phase 1 Phase 2

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; 800 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 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Vaginal Microbiome Seeding and Health Outcomes in Cesarean-delivered Neonates: a Randomized Controlled Trial
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : July 1, 2023
Estimated Study Completion Date : July 1, 2025

Arm Intervention/treatment
Active Comparator: Receives Vaginal Seeding Biological: Vaginal Seeding
A gauze containing the Mother's vaginal flora will be swabbed over the face and body of the neonate shortly after cesarean delivery.

Sham Comparator: No Vaginal Seeding Other: No Vaginal Seeding
A gauze carrying sterile saline will be swabbed over the face and body of the neonate shortly after cesarean delivery.




Primary Outcome Measures :
  1. Intestinal microbiota [ Time Frame: 3 months ]
    Intestinal microbiota at 3 months of age


Secondary Outcome Measures :
  1. Adiposity [ Time Frame: 3 years ]
    E.g. Body mass index z-score

  2. Adverse events [ Time Frame: 3 years ]
    Monitoring for adverse events

  3. Immune regulation [ Time Frame: 3 years ]
    E.g. Monitoring for immune mediated conditions

  4. Intestinal microbiota [ Time Frame: 3 years ]
    Intestinal microbiota development over the first three years of life



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Ages Eligible for Study:   up to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 pregnancy
  • Negative testing for GBS at 35-37 weeks gestation
  • Vaginal pH < 4.5 indicative of Lactobacillus-dominated vaginal microbiota
  • No maternal or fetal complications that may inhibit the ability to perform microbiome restoration per protocol
  • English or Spanish speaking

Inclusion Criteria for Infant:

-Infant condition after delivery requires no more than standard neonatal resuscitation* or is otherwise medically unable to receive the full VMT procedure

*Standard neonatal resuscitation includes: tactile stimulation, bulb suction, and drying

Exclusion Criteria for Mother:

  • Delivery at a hospital other than Inova Women's Center
  • Current immunosuppressive medication including biological agent within three months of cesarean delivery
  • CD scheduled for active infection that would have interfered with vaginal delivery such as genital herpetic lesions
  • Onset of labor or rupture of membranes prior to scheduled CD
  • Bacterial vaginosis
  • Symptomatic urinary tract infection
  • Antibiotic therapy within 30 days of cesarean delivery (exclusive of medication use for prophylaxis at the time of surgery)
  • Symptoms on admission suggesting Chorioamnionitis, e.g. maternal fever, fundal tenderness
  • Symptoms on delivery admission of possible vaginal infection such as genital herpetic lesions
  • History positive testing for GBS infection
  • History of a child with a diagnosis of GBS sepsis
  • Pregnancy a result of donor egg or surrogacy
  • Preexisting history of Type I or Type II Diabetes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03298334


Contacts
Contact: Suchitra Hourigan, MD 703-776-8199 suchitra.hourigan@inova.org
Contact: Kathi Huddleston 703-776-8199 kathi.huddleston@inova.org

Locations
United States, Virginia
Inova Fairfax Hospital Recruiting
Falls Church, Virginia, United States, 22042
Contact: Suchitra Hourigan, MD    703-776-8199    suchitra.hourigan@inova.org   
Sub-Investigator: Ankit Shah, MD         
Sponsors and Collaborators
Inova Health Care Services
Johns Hopkins University
Rutgers University
Investigators
Principal Investigator: Suchitra Hourigan, MD Inova Translational Medicine Institute
Principal Investigator: Noel Mueller, PhD Johns Hopkins University
Principal Investigator: Maria Gloria Dominguez Bello, PhD Rutgers University

Publications of Results:
Responsible Party: Suchitra Hourigan, Director of microbiome research, Inova Translational Medicine Institute. Pediatric Gastroenterologist., Inova Health Care Services
ClinicalTrials.gov Identifier: NCT03298334     History of Changes
Other Study ID Numbers: 17-2694
First Posted: October 2, 2017    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data will be shared with co-principal investigators (Maria Glora Dominguz Bello at Rutgers University and Noel Mueller at Johns Hopkins School of Medicine) and with the funder Commense.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms