Intestinal Microbiota Survey of Polycystic Ovary Syndrome

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02937090
• Other study ID #: PCOS2016
• Status: Completed
• Phase: N/A
• First received: October 14, 2016
• Last updated: November 1, 2017
• Start date: May 2016
• Est. completion date: October 2017

Study information

• Verified date: November 2017
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Other:
• Blood Draw
Blood sample will be drawn from participants at study entry.
• Stool collection
Stool will be collected from participants at study entry.

Locations

Country	Name	City	State
China	Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intestinal microbiota of stool samples of PCOS and age, BMI-matched control will be identified by quantitative analysis.		an average of 1 month
Secondary	Correlation of intestinal microbiota composition with biological parameters of PCOS patients will be assessed.		an average of 1 month