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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 : June 14, 2019
Sponsor:
Collaborators:
Johns Hopkins University
Rutgers University
Information provided by (Responsible Party):
Suchitra Hourigan, Inova Health Care Services

Tracking Information
First Submitted Date  ICMJE September 27, 2017
First Posted Date  ICMJE October 2, 2017
Last Update Posted Date June 14, 2019
Actual Study Start Date  ICMJE July 1, 2018
Estimated Primary Completion Date July 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2019)
Adiposity [ Time Frame: 2 years ]
E.g. Body mass index z-score
Original Primary Outcome Measures  ICMJE
 (submitted: September 27, 2017)
Intestinal microbiota [ Time Frame: 3 months ]
Intestinal microbiota at 3 months of age
Change History Complete list of historical versions of study NCT03298334 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2019)
  • Adverse events [ Time Frame: 3 years ]
    Monitoring for adverse events
  • Intestinal microbiota [ Time Frame: 3 years ]
    Intestinal microbiota development over the first three years of life
  • Immune regulation [ Time Frame: 3 years ]
    E.g. Monitoring for immune mediated conditions
Original Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2017)
  • Adiposity [ Time Frame: 3 years ]
    E.g. Body mass index z-score
  • Adverse events [ Time Frame: 3 years ]
    Monitoring for adverse events
  • Immune regulation [ Time Frame: 3 years ]
    E.g. Monitoring for immune mediated conditions
  • Intestinal microbiota [ Time Frame: 3 years ]
    Intestinal microbiota development over the first three years of life
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vaginal Microbiome Seeding and Health Outcomes in Cesarean-delivered Neonates.
Official Title  ICMJE Vaginal Microbiome Seeding and Health Outcomes in Cesarean-delivered Neonates: a Randomized Controlled Trial
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 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Cesarean Delivery Affecting Newborn
  • Obesity, Childhood
  • Intestinal Microbiome
Intervention  ICMJE
  • 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.
  • Other: No Vaginal Seeding
    A gauze carrying sterile saline will be swabbed over the face and body of the neonate shortly after cesarean delivery.
Study Arms  ICMJE
  • Active Comparator: Receives Vaginal Seeding
    Intervention: Biological: Vaginal Seeding
  • Sham Comparator: No Vaginal Seeding
    Intervention: Other: No Vaginal Seeding
Publications * Dominguez-Bello MG, De Jesus-Laboy KM, Shen N, Cox LM, Amir A, Gonzalez A, Bokulich NA, Song SJ, Hoashi M, Rivera-Vinas JI, Mendez K, Knight R, Clemente JC. Partial restoration of the microbiota of cesarean-born infants via vaginal microbial transfer. Nat Med. 2016 Mar;22(3):250-3. doi: 10.1038/nm.4039. Epub 2016 Feb 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 8, 2019)
600
Original Estimated Enrollment  ICMJE
 (submitted: September 27, 2017)
800
Estimated Study Completion Date  ICMJE July 1, 2025
Estimated Primary Completion Date July 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  • Negative maternal testing for Gonorrhea, Chlamydia, Hepatitis B, Hepatitis C, Syphilis, and HIV at 35 weeks gestation or later
  • Women aged 21-29 years should have a normal Pap test within 3 years
  • Women aged 30-65 years should have a normal Pap test and an HPV test (co-testing) within 5 years or a normal Pap test alone within 3 years

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 may include: tactile stimulation, bulb suction, oxygen without positive pressure and drying

Exclusion Criteria for Mother:

  • Delivery at a hospital other than Inova Health System
  • Systemic medication for immunosuppression including biological agent within three months of cesarean delivery (exclusive of medications used for non-immunosuppressive purposes - e.g. betamethasone for fetal lung maturation)
  • 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
  • Maternal history of documented genital HPV infection, positive HPV testing or genital warts on physician examination
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 50 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Suchitra Hourigan, MD 703-776-8199 suchitra.hourigan@inova.org
Contact: Shira Levy 703-776-8199 shira.levy@inova.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03298334
Other Study ID Numbers  ICMJE 17-2694
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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).
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Responsible Party Suchitra Hourigan, Inova Health Care Services
Study Sponsor  ICMJE Inova Health Care Services
Collaborators  ICMJE
  • Johns Hopkins University
  • Rutgers University
Investigators  ICMJE
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
PRS Account Inova Health Care Services
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP