Pilot Study: Identification of a Multi-omic Predictive Signature for Preterm Birth in Obese African American Women

Obesity Clinical Trial

Official title:

Pilot Study: Identification of a Multi-omic Predictive Signature for Preterm Birth in Obese African American Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03181555
• Other study ID #: 916539
• Status: Completed
• Phase: N/A
• First received: December 9, 2016
• Last updated: September 19, 2017
• Start date: August 2016
• Est. completion date: August 2017

Study information

• Verified date: September 2017
• Source: Baylor University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• PREG1
• Premature Birth

Intervention

Other:
• Exploratory

Locations

Country	Name	City	State
United States	MacArthur OB/GYN	Irving	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	27-28 weeks to 39 weeks of pregnancy
Secondary	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	27-28 weeks to 39 weeks of pregnancy