Potential Restoration of the Infant Microbiome (PRIME)
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02407184|
Recruitment Status : Withdrawn (Dr. Bello is no longer a PI at the institution. Data analysis was not completed.)
First Posted : April 2, 2015
Last Update Posted : January 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Human Microbiome||Other: Newborn exposure to mother vaginal microbiota||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Potential Restoration of the Infant Microbiome|
|Study Start Date :||April 2015|
|Actual Primary Completion Date :||January 2018|
|Actual Study Completion Date :||January 2018|
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.
- 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.
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
|United States, New York|
|New York, New York, United States, 10010|
|Principal Investigator:||Maria Gloria Dominguez-Bello, PhD||NYU School of Medicine|