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Potential Restoration of the Infant Microbiome (PRIME)

This study is currently recruiting participants.
Verified March 2017 by New York University School of Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT02407184
First Posted: April 2, 2015
Last Update Posted: March 16, 2017
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.
Information provided by (Responsible Party):
New York University School of Medicine
  Purpose
Understanding the microbiome's important role in human health, the investigators wish to determine how the development of the infant microbiome is impacted by delivery mode, comparing natural vaginal birth to scheduled C-sections. Investigators will look at the oral, nasal, skin, vaginal and fecal bacteria of 78 mothers and their infants from birth to age 1.

Condition Intervention
Human Microbiome Other: Newborn exposure to mother vaginal microbiota

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Potential Restoration of the Infant Microbiome

Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Bacterial diversity of several body sites on mother and baby throughout one year post-birth as measured by the number and type of different bacteria present [ Time Frame: Day of Birth; Days 1 and 3; Weeks 1, 2, 3 and 4; Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11; Year 1 ]
    Investigators will first use Illumina to obtain sequences of the bacterial mitochondrial DNA from collected samples. QIIME, LEfSe, and other bioinformatic tools will then be used to calculate the bacterial diversity (richness, relative abundances) in each sample, as well as compare bacterial communities (beta diversity), sourcetracking to determine origin from maternal sites, random forest to classify communities, and other tools to describe the dynamics of the infant microbiome.


Estimated Enrollment: 78
Study Start Date: April 2015
Estimated Study Completion Date: February 2019
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Scheduled C-section
Babies that are scheduled to be born in a hospital via standard C-section procedure.
No Intervention: Vaginal Delivery
Babies that are born via vaginal delivery, either at home, at a birthing center or hospital. Drugs may be administered during labor.
Experimental: Scheduled C-section with Exposure
Babies that are scheduled to be born in a hospital via standard C-section procedure, as well as are swabbed with gauze containing their mother's vaginal microbiota just after delivery. The intervention: Newborn exposure to mother vaginal microbiota.
Other: Newborn exposure to mother vaginal microbiota
Babies are swabbed just after delivery with gauze containing their mother's vaginal microbiota.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for ALL subjects:

  • Healthy mothers, 18-40 years old with uncomplicated pregnancies delivering at term (37 weeks or later)
  • Mothers of any ethnic or social background that can speak, read, and understand English to the extent that they can consent in English OR mothers who do not speak English yet agree to come to an NYU hospital for all sampling.

Additional inclusion criteria for mothers in the C-section with exposure to the vaginal environment group (CS+E):

  • Scheduled C-section
  • Vaginal pH ≤ 4 at the time of birth (as measured via pH paper)

Exclusion Criteria for ALL subjects:

  • Mothers with pre-eclampsia or other serious chronic conditions
  • Mothers with complicated pregnancies
  • Mothers under 18 years of age or over 40 years of age
  • Babies with complications during delivery
  • Babies delivered prior to 37 weeks of gestation

Additional exclusion criteria for mothers in the C-section with exposure to the vaginal environment group (CS+E):

  • Mothers reported positive to active primary herpes, genital warts, HIV, Group B Streptococcus, gonorrhea, chlamydia, bacterial vaginosis, yeast infection, or trichomoniasis.
  • Mothers with vaginal pH > 4 at the time of birth (as measured via pH paper).
  • Known positive Group B Strep test results by rectal vaginal swab within five weeks of the scheduled caesarian.
  Contacts and Locations
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): NCT02407184


Contacts
Contact: Deanna Nardella 6465010122 Deanna.Nardella@nyumc.org
Contact: Elizabeth Bakacs 9785025479 Elizabeth.Bakacs@med.nyu.edu

Locations
United States, New York
Recruiting
New York, New York, United States, 10010
Contact: Maria Dominguez-Bello         
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Maria Gloria Dominguez-Bello, PhD NYU School of Medicine
  More Information

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02407184     History of Changes
Other Study ID Numbers: 14-01446
First Submitted: March 5, 2015
First Posted: April 2, 2015
Last Update Posted: March 16, 2017
Last Verified: March 2017

Keywords provided by New York University School of Medicine:
Microbiota
Microbiome