Intestinal Microbiota Survey of Polycystic Ovary Syndrome

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02937090

Enrollment

Registered

2016-10-18

Start date

2016-05-31

Completion date

2017-10-31

Last updated

2017-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic Ovary Syndrome, Intestinal Microbiota

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 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.

Interventions

OTHERBlood Draw

Blood sample will be drawn from participants at study entry.

OTHERStool collection

Stool will be collected from participants at study entry.

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Intestinal microbiota of stool samples of PCOS and age, BMI-matched control will be identified by quantitative analysis.	an average of 1 month

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026