Clinical trial NCT02937090: Intestinal Microbiota Survey of Polycystic Ovary Syndrome
Official title: The Cross-sectional Study of Intestinal Microbiota in Women With Polycystic Ovary Syndrome and Its Association With Clinical and Biological Parameters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome
Keywords: Polycystic Ovary Syndrome
Intestinal Microbiota
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2016-10-18
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Polycystic Ovary Syndrome patients and age, BMI-matched women.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intestinal microbiota of stool samples of PCOS and age, BMI-matched control will be identified by quantitative analysis.
timeFrame: an average of 1 month
Secondary outcomes:
measure: Correlation of intestinal microbiota composition with biological parameters of PCOS patients will be assessed.
timeFrame: an average of 1 month
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
state: Jiangsu
Study officials:
References: