Pilot Study: Identification of a Multi-omic Predictive Signature for Preterm Birth in Obese African American Women
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss, Women's Studies |
| Therapuetic Areas: | Endocrinology, Reproductive |
| Healthy: | No |
| Age Range: | 20 - Any |
| Updated: | 6/10/2017 |
| Start Date: | August 2016 |
| End Date: | August 2017 |
| Contact: | Mary Ann Faucher, PhD, MPH |
| Email: | maryann_faucher@baylor.edu |
| Phone: | 214-820-4498 |
1. 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
2. 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.
3. 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.
4. Determine if any dietary or clinical variables are correlated with changes in the
microbiome or urinary metabolites or modify their association with PTB
pregnant obese population of African American women differ from their pregnant
non-obese counterparts
2. 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.
3. 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.
4. Determine if any dietary or clinical variables are correlated with changes in the
microbiome or urinary metabolites or modify their association with PTB
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.
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.
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
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