Vaginal Microbiome Seeding and Health Outcomes in Cesarean-delivered Neonates.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03298334|
Recruitment Status : Recruiting
First Posted : October 2, 2017
Last Update Posted : August 18, 2020
|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|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|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.
- Adiposity [ Time Frame: 2 years ]E.g. Body mass index z-score
- 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 and inflammatory regulation [ Time Frame: 3 years ]E.g. Monitoring for immune and inflammatory mediated conditions
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
|Contact: Suchitra Hourigan, MDemail@example.com|
|Contact: Shira Levyfirstname.lastname@example.org|
|United States, Virginia|
|Inova Health System||Recruiting|
|Falls Church, Virginia, United States, 22042|
|Contact: Suchitra Hourigan, MD 703-776-8199 email@example.com|
|Sub-Investigator: Ankit Shah, MD|
|Principal Investigator:||Suchitra Hourigan, MD||Inova Children's Hospital|
|Principal Investigator:||Noel Mueller, PhD||Johns Hopkins University|
|Principal Investigator:||Maria Gloria Dominguez Bello, PhD||Rutgers University|
|Principal Investigator:||Lawrence Appel, MD, MPH||Johns Hopkins University|