Back to resultsPilot Study: Identification of a Multi-omic Predictive Signature for Preterm Birth in Obese African American Women
Primary Purpose
PREG1, Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exploratory
Sponsored by
About this trial
This is an interventional basic science trial for PREG1 focused on measuring Pregnant, Obese, Omic
Eligibility Criteria
Inclusion Criteria:
- Age 20 or older English Speaking Access to internet- The dietary assessment for this study is The Automated Self-Administered 24-hour Recall (ASA24-2014), a web-based instrument developed by researchers at the National Cancer Institute (NCI).
Exclusion Criteria:
- 1. History of preterm birth and taking progesterone. Progesterone may influence the microbiota and metabolites so therefore these women will not be eligible for the study. However, if the women fit other inclusion criteria and have a history of preterm birth but are not on progesterone they will be eligible for enrollment 2. History of antibiotic use in the last month (includes pre-biotics and probiotics). These medications will change the baseline microbiota.
3. History of chronic disease on medications
Sites / Locations
- MacArthur OB/GYN
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Pregnant Obese African American Women
Arm Description
Exploratory
Outcomes
Primary Outcome Measures
1. Differences in vaginal and gut microbiome and urinary metabolites profile between obese and nonobese pregnant AA women
The vaginal and gut microbiome and urine metabolites in obese women AA women will be compared with non-obese pregnant AA women. This comparison will be investigated by diet and gestational weight gain
Secondary Outcome Measures
Differences in vaginal and gut microbiome and urinary metabolites profile between by class of obesity in pregnant AA women
The vaginal and gut microbiome and urine metabolites in obese women AA women will be compared by class of obesity. This comparison will be investigated by diet and gestational weight gain
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03181555
Brief Title
Pilot Study: Identification of a Multi-omic Predictive Signature for Preterm Birth in Obese African American Women
Official Title
Pilot Study: Identification of a Multi-omic Predictive Signature for Preterm Birth in Obese African American Women
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Determine if the stool or vaginal microbiome and urinary metabolite profiles in a pregnant obese population of African American women differ from their pregnant non-obese counterparts
Determine if the stool or vaginal microbiome and urinary metabolite profiles vary by class of obesity and magnitude of excess weight gain in this population of pregnant African-American women.
Assess the ability of the stool, vaginal microbiome, or metabolites, or the combination of all biomarkers as predictors of preterm birth (PTB) and onset of labor.
Determine if any dietary or clinical variables are correlated with changes in the microbiome or urinary metabolites or modify their association with PTB
Detailed Description
This is an exploratory pilot study to determine the omic footprint in pregnant AA women and then compare difference between obese and non-obese pregnant AA women and comparisons by class of obesity. Variations in the omic findings (vaginal and gut microbiome and urinary metabolites) will be assessed by dietary findings and by variations in gestational weight gain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PREG1, Obesity
Keywords
Pregnant, Obese, Omic
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
No masking. A convenience sample of pregnant AA women will be recruited based on race/ethnicity and body mass index.
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pregnant Obese African American Women
Arm Type
Other
Arm Description
Exploratory
Intervention Type
Other
Intervention Name(s)
Exploratory
Primary Outcome Measure Information:
Title
1. Differences in vaginal and gut microbiome and urinary metabolites profile between obese and nonobese pregnant AA women
Description
The vaginal and gut microbiome and urine metabolites in obese women AA women will be compared with non-obese pregnant AA women. This comparison will be investigated by diet and gestational weight gain
Time Frame
27-28 weeks to 39 weeks of pregnancy
Secondary Outcome Measure Information:
Title
Differences in vaginal and gut microbiome and urinary metabolites profile between by class of obesity in pregnant AA women
Description
The vaginal and gut microbiome and urine metabolites in obese women AA women will be compared by class of obesity. This comparison will be investigated by diet and gestational weight gain
Time Frame
27-28 weeks to 39 weeks of pregnancy
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 20 or older English Speaking Access to internet- The dietary assessment for this study is The Automated Self-Administered 24-hour Recall (ASA24-2014), a web-based instrument developed by researchers at the National Cancer Institute (NCI).
Exclusion Criteria:
- 1. History of preterm birth and taking progesterone. Progesterone may influence the microbiota and metabolites so therefore these women will not be eligible for the study. However, if the women fit other inclusion criteria and have a history of preterm birth but are not on progesterone they will be eligible for enrollment 2. History of antibiotic use in the last month (includes pre-biotics and probiotics). These medications will change the baseline microbiota.
3. History of chronic disease on medications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Ann Faucher, PhD
Organizational Affiliation
Baylor University
Official's Role
Principal Investigator
Facility Information:
Facility Name
MacArthur OB/GYN
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pilot Study: Identification of a Multi-omic Predictive Signature for Preterm Birth in Obese African American Women
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