Intestinal Microbiota Survey of Polycystic Ovary Syndrome
NCT ID: NCT02937090
Last Updated: 2017-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
80 participants
OBSERVATIONAL
2016-05-31
2017-10-31
Brief Summary
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Detailed Description
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Aim 1. Identify and enroll cohort with PCOS and age, BMI-matched control to study the role of intestinal microbiota on the development of PCOS.
1. Enroll participants at Drum Tower Hospital. Identify and classify participants through initial clinical evaluation, collect clinical metadata, obtain and process blood and stool samples for analysis.
2. Characterize the intestinal microbiota through quantitative PCR and high throughput sequencing analysis of stool specimens in participants.
Aim 2. Compare sequencing results and metagenomic analysis for study groups with particular attention to bacterial composition and metabolic capacity associated with energy harvest, lipid and carbohydrate transport, enhancement of epithelial barrier integrity and systemic inflammation.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Polycystic Ovary Syndrome
Premenopausal women between 18-40 years of age.
Diagnosed with PCOS using Rotterdam criteria (meet 2 of the 3):
1. chronic oligo- or amenorrhea (irregular periods during more than a year in combination with a cycle length longer than 35 days);
2. total or free T levels above the reference interval and/or excessive facial hair, acne;
3. transvaginal ultrasound with polycystic ovaries.
Exclusion of common medical disorders (normal thyroid function tests and serum prolactin and exclusion of 21-hydroxylase deficiency).
Blood Draw
Blood sample will be drawn from participants at study entry.
Stool collection
Stool will be collected from participants at study entry.
Control
Women matched for age and BMI.
Blood Draw
Blood sample will be drawn from participants at study entry.
Stool collection
Stool will be collected from participants at study entry.
Interventions
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Blood Draw
Blood sample will be drawn from participants at study entry.
Stool collection
Stool will be collected from participants at study entry.
Eligibility Criteria
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Inclusion Criteria
2. Exclusion of other etiologies for infertility.
Exclusion Criteria
2. Use of antibiotics within 3 months.
3. Regular use of proton pump inhibitors, laxatives or pro-prebiotics.
4. Previous history of gastrointestinal surgery or disease (such as peptic ulcer, irritable bowel syndrome, inflammatory bowel disease or other gastrointestinal disorder).
5. Major changes in eating habits within the past 3 months.
18 Years
40 Years
FEMALE
Yes
Sponsors
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
Responsible Party
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Dalong Zhu
Chief Physician
Locations
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Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, China
Countries
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Other Identifiers
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PCOS2016
Identifier Type: -
Identifier Source: org_study_id