An observational study in Polycystic Ovary Syndrome, sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. Completed at 1 site in China. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-06.
Sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Observational
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.
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.
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.
944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.
This study's enrollment of 80 is below the median of 118 across 223 observational studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School is the lead sponsor of 242 studies on the registry; 144 are open to participants now.
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Polycystic Ovary Syndrome patients and age, BMI-matched women.
Inclusion Criteria:
Exclusion Criteria:
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).
Other: Blood Draw · Other: Stool collection
Women matched for age and BMI.
Other: Blood Draw · Other: Stool collection
Blood sample will be drawn from participants at study entry.
Stool will be collected from participants at study entry.
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
Correlation of intestinal microbiota composition with biological parameters of PCOS patients will be assessed.
Time frame: an average of 1 month
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School