Intestinal Microbiota Survey of Polycystic Ovary Syndrome

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Other: Blood Draw; Other: Stool collection

• Registration Number: NCT02937090
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-10-14
• Study First Submitted QC: 2016-10-15
• Study First Posted: 2016-10-18
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-01
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Stool collection	Women matched for age and BMI.
Control	Blood Draw	Women matched for age and BMI.
Polycystic Ovary Syndrome	Stool collection	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).
Polycystic Ovary Syndrome	Blood Draw	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).

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University; 🇨🇳 Nanjing, Jiangsu, China