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Intestinal Microbiota Survey of Polycystic Ovary Syndrome

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ClinicalTrials.gov Identifier: NCT02937090
Recruitment Status : Completed
First Posted : October 18, 2016
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Dalong Zhu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study Description
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Brief Summary:
Polycystic Ovary Syndrome is kind of disease with unclear etiology. Recent studies on intestinal microbiota have raised the possibility that dysbiosis of intestinal microbiota maybe a novel theory for the development of Polycystic Ovary Syndrome. Hence, the investigators will compare the intestinal microbiota composition and diversity in PCOS with age, BMI-matched control and then assess whether intestinal microbiota modification is associated with clinical and biological parameters.

Condition or disease Intervention/treatment
Polycystic Ovary Syndrome Other: Blood Draw Other: Stool collection

Detailed Description:

The goal of this study is to investigate and compare the composition of the intestinal microbiota in patients with PCOS and age, BMI-matched control. In addition, the investigators will investigate the relationship between alterations in the intestinal microbiota, clinical phenotype, biochemical analysis, body composition, inflammation and food consumption habit. The investigators hypothesize that alterations in the intestinal microbiota are associated with increased immune activation and progression of PCOS. Based on this hypothesis, the investigators propose the following aims:

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.

Study Design
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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: The Cross-sectional Study of Intestinal Microbiota in Women With Polycystic Ovary Syndrome and Its Association With Clinical and Biological Parameters
Study Start Date : May 2016
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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).

 Other: Blood Draw
Blood sample will be drawn from participants at study entry.

Other: Stool collection
Stool will be collected from participants at study entry.
Control
Women matched for age and BMI.
 Other: Blood Draw
Blood sample will be drawn from participants at study entry.

Other: Stool collection
Stool will be collected from participants at study entry.


Outcome Measures
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Primary Outcome Measures :
  1. Intestinal microbiota of stool samples of PCOS and age, BMI-matched control will be identified by quantitative analysis. [ Time Frame: an average of 1 month ]

Secondary Outcome Measures :
  1. Correlation of intestinal microbiota composition with biological parameters of PCOS patients will be assessed. [ Time Frame: an average of 1 month ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Polycystic Ovary Syndrome patients and age, BMI-matched women.
Criteria

Inclusion Criteria:

  1. Premenopausal between 18-40 years of age.
  2. Exclusion of other etiologies for infertility.

Exclusion Criteria:

  1. During the pregnancy and lactation period.
  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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02937090


Locations
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China, Jiangsu
Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, China, 210008
Sponsors and Collaborators
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
More Information
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Responsible Party: Dalong Zhu, Chief Physician, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier: NCT02937090    
Other Study ID Numbers: PCOS2016
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dalong Zhu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School:
Polycystic Ovary Syndrome
Intestinal Microbiota
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
 Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases