Potential Restoration of the Infant Microbiome

NCT02407184 | Withdrawn DMC

• 1 other identifier: 14-01446
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Human Microbiome

Keywords

Microbiota; Microbiome

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  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

Study Arms (3)

Scheduled C-section

NO INTERVENTION

Babies that are scheduled to be born in a hospital via standard C-section procedure.

Vaginal Delivery

NO INTERVENTION

Babies that are born via vaginal delivery, either at home, at a birthing center or hospital. Drugs may be administered during labor.

Scheduled C-section with Exposure

EXPERIMENTAL

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

Interventions

Newborn exposure to mother vaginal microbiota OTHER

Babies are swabbed just after delivery with gauze containing their mother's vaginal microbiota.

Scheduled C-section with Exposure

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

Unknown Facility

New York, New York, 10010, United States

Location

Study Officials

• Maria Gloria Dominguez-Bello, PhD

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2015
• First Posted: April 2, 2015
• Study Start: April 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: January 12, 2018

Record last verified: 2018-01

Locations

US (1)