RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2018-07-01
Study Completion:2029-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03298334

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:0 Days to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Suchitra Hourigan, MD
CONTACT
703-776-8489
suchitra.hourigan@inova.org, suchitra.hourigan@nih.gov
Shira Levy
CONTACT
703-776-8489
shira.levy@inova.org

Principal Investigator

Suchitra Hourigan, MD, Chief, Clinical Microbiome Unit, NIAID, Pediatric Gastroenterologist
PRINCIPAL_INVESTIGATOR
National Institute of Allergy and Infectious Diseases (NIAID), Inova Children's Hospital
Noel Mueller, PhD
PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Maria Gloria Dominguez Bello, PhD
PRINCIPAL_INVESTIGATOR
Rutgers University
Lawrence Appel, MD, MPH
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

Inova Health System
Falls Church, Virginia, 22042
United States

Collaborators and Investigators

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

  • Suchitra Hourigan, MD, Chief, Clinical Microbiome Unit, NIAID, Pediatric Gastroenterologist, PRINCIPAL_INVESTIGATOR, National Institute of Allergy and Infectious Diseases (NIAID), Inova Children's Hospital
  • Noel Mueller, PhD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University
  • Maria Gloria Dominguez Bello, PhD, PRINCIPAL_INVESTIGATOR, Rutgers University
  • Lawrence Appel, MD, MPH, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-07-01
Study Completion Date2029-04

Study Record Updates

Study Start Date2018-07-01
Study Completion Date2029-04

Terms related to this study

Additional Relevant MeSH Terms

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