Intestinal Microbiota Survey of Polycystic Ovary Syndrome
Клучни зборови
Апстракт
Опис
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.
Датуми
| Последен пат проверено: | 10/31/2017 |
| Прво доставено: | 10/13/2016 |
| Поднесено е проценето запишување: | 10/14/2016 |
| Прво објавено: | 10/17/2016 |
| Последното ажурирање е доставено: | 10/31/2017 |
| Последно ажурирање објавено: | 11/05/2017 |
| Крај на датумот на започнување на студијата: | 04/30/2016 |
| Проценет датум на примарно завршување: | 09/30/2017 |
| Проценет датум на завршување на студијата: | 09/30/2017 |
Состојба или болест
Интервенција / третман
Other: Blood Draw
Other: Stool collection
Фаза
Групи за раце
| Рака | Интервенција / третман |
|---|---|
| Polycystic Ovary Syndrome Premenopausal women between 18-40 years of age.
Diagnosed with PCOS using Rotterdam criteria (meet 2 of the 3):
chronic oligo- or amenorrhea (irregular periods during more than a year in combination with a cycle length longer than 35 days);
total or free T levels above the reference interval and/or excessive facial hair, acne;
transvaginal ultrasound with polycystic ovaries.
Exclusion of common medical disorders (normal thyroid function tests and serum prolactin and exclusion of 21-hydroxylase deficiency). | |
| Control Women matched for age and BMI. |
Критериуми за подобност
| Возраст подобни за студии | 18 Years До 18 Years |
| Полови квалификувани за студии | Female |
| Метод на земање примероци | Probability Sample |
| Прифаќа здрави волонтери | Да |
| Критериуми | 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. |
Исход
Мерки на примарниот исход
1. Intestinal microbiota of stool samples of PCOS and age, BMI-matched control will be identified by quantitative analysis. [an average of 1 month]
Секундарни мерки на исходот
1. Correlation of intestinal microbiota composition with biological parameters of PCOS patients will be assessed. [an average of 1 month]
