Intestinal Microbiota Survey of Polycystic Ovary Syndrome

November 1, 2017 updated by: Dalong Zhu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

The Cross-sectional Study of Intestinal Microbiota in Women With Polycystic Ovary Syndrome and Its Association With Clinical and Biological Parameters

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Polycystic Ovary Syndrome patients and age, BMI-matched women.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
an average of 1 month

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

October 14, 2016

First Submitted That Met QC Criteria

October 15, 2016

First Posted (Estimate)

October 18, 2016

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

November 1, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCOS2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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