PREG1NCT03181555
Pilot Study: Identification of a Multi-omic Predictive Signature for Preterm Birth in Obese African American Women
A study testing Exploratory in people with PREG1 and Obesity, run by Baylor University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- What is being tested?
- Exploratory
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
- 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
Read the 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.
- Being tested
- Exploratory
- Keywords
- Pregnant, Obese, Omic
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExploratoryOther
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Obese African American Women | Other | Exploratory Receives: Other: Exploratory |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 27-28 weeks to 39 weeks of pregnancy
Secondary outcomes (1)
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
Measured: 27-28 weeks to 39 weeks of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study startAug 2016
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PREG1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Ann Faucher, Baylor University
- Investigators
- Mary Ann Faucher, PhD, Principal investigator, Baylor University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03181555
- Sponsor's protocol ID
- 916539
- Status last verified
- Sep 2017
- First submitted
- 9 Dec 2016
- Last updated
- 21 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Identification of a Multi-omic Predictive Signature for Preterm Birth in Obese African American Women
- ClinicalTrials.gov ID
- NCT03181555
- Acronym / sponsor ID
- 916539
- Keywords
- Pregnant, Obese, Omic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Baylor UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 9 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant Obese African American Women | Other | Other: ExploratoryExploratory |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exploratory | Other | Pregnant Obese African American Women |
Primary outcome
1. Differences in vaginal and gut microbiome and urinary metabolites profile between obese and nonobese pregnant AA women
Time frame: 27-28 weeks to 39 weeks of pregnancy
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
1 secondary outcome
Differences in vaginal and gut microbiome and urinary metabolites profile between by class of obesity in pregnant AA women
Time frame: 27-28 weeks to 39 weeks of pregnancy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Ann Faucher, PhD principal investigator
Baylor University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exploratory in people with PREG1 and Obesity, run by Baylor University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Differences in vaginal and gut microbiome and urinary metabolites profile between obese and nonobese pregnant AA women (time frame: 27-28 weeks to 39 weeks of pregnancy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2017.