Clinical Trial: Intestinal Microbiota Survey of Polycystic Ovary Syndrome
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: The Cross-sectional Study of Intestinal Microbiota in Women With Polycystic Ovary Syndrome and Its Association With Clinical and Biological Parameters
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.
Detailed Summary:
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.
- 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.
- 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.
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Correlation of intestinal microbiota composition with biological parameters of PCOS patients will be assessed. [ Time Frame: an average of 1 month ]
Original Secondary Outcome: Same as current
Information By: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Dates:
Date Received: October 14, 2016
Date Started: May 2016
Date Completion: October 2017
Last Updated: October 15, 2016
Last Verified: October 2016
