The Change in Microbiome Following Treatment of Women With Polycystic Ovaries
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Vaginal and gut microbiota composition before and after intervention recommended and in comparison to women without PCOS.
研究概览
简要总结
Polycystic Ovary Syndrome (PCOS) is the most common endocrine disorder among women in reproductive age with an estimated prevalence of 5% to 19.5%. It is a chronic complex syndrome with psychological (depression and anxiety), reproductive and metabolic abnormalities. The etiology seems to be multifactorial. Lately, interest regarding the association between PCOS women and gut macrobiotic have been emerged. Hyperandrogenism was correlated with those changes in the microbiota which reflects the fact that the microbiome can influence the development and pathology of PCOS .
Therefore, aim of this study is to explore the diversity and alternations of the vaginal and the gut microbiome in patients with PCOS during common therapeutic interventions and connect them to different phenotypes of the syndrome.
详细描述
Polycystic Ovary Syndrome (PCOS) is the most common endocrine disorder among women in reproductive age with an estimated prevalence of 5% to 19.5%. It is a chronic complex syndrome with psychological (depression and anxiety), reproductive and metabolic abnormalities. The etiology seems to be multifactorial. It seems there are both genetic, epigenetic and environmental contributors (almost 100 susceptible genes were identified).
The quality of life (QQL) of women suffering from PCOS is significantly reduced in all domains (functional ability, physical and emotional) and major health problems is correlated to PCOS. Women with PCOS demonstrate hyperinsulinemia and insulin resistance. They have an increased risk for type 2 diabetes and impaired glucose tolerance. Studies have shown that adipocyte function is considerably aberrant in women with PCOS including: lower lipase activity, defective glucose transport and dyslipidemia. Obesity is more prevalent in women with PCOS. They are also exposed to long term risk for additional disorders like cardiovascular diseases (atherosclerosis) or even cancer (endometrial or ovarian) .
PCOS is the primary cause of anovulatory subfertility. Furthermore, women with PCOS are at risk for pregnancy and obstetrical complications including preterm birth, pre- eclampsia and meconium aspiration syndrome of neonates after birth.
PCOS is diagnosed according the Rotterdam criteria . It requires 2 out of 3 symptoms: 1. Hyperandrogenism or excess levels of androgen)- clinical and/ or biochemical (presence of hirsutism, acne or alopecia). 2. Oligo or anovulation (including menstrual dysfunction). 3. PCO-M polycystic ovaries morphology (over 12 follicles, 2-9 mm or increased ovarian volume).
The term microbiome describes the genetic material of all the microbes (bacteria, fungi, protozoa and viruses) that live onside and inside the human body. It is important for development of the body, immunity and nutrition. The microbiome may influence the susceptibility to different infectious diseases and contribute to chronic illnesses.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Study group: Untreated women diagnosed with PCOS that are planned for intervention.
- •Control group: Women without PCOS visiting the gynecologic outpatient's clinics.
排除标准
- •Endocrine abnormality ( Cushing's syndrome, congenital adrenal hyperplasia, thyroid disorder, hyperprolactinemia and androgen-secreting tumor).
- •Premature ovarian failure
- •Active malignancy
- •Participants taking antibiotics/ probiotics, hormonal, vaginal or laxative medicine (in the previous week).
- •Vaginitis/ Pelvic Inflammatory Disease (PID)
研究组 & 干预措施
Study Group: Women with Polycystic Ovary Syndrome
Woen diagnosed with Polycystic Ovary Syndrome according to the Rotterdam Criteria (requires 2 out of 3 symptoms: 1. Hyperandrogenism or excess levels of androgen. 2. Oligo or anovulation. 3. Polycystic ovaries on ultrasound - over 12 follicles, 2-9 mm or increased ovarian volume),who haven't started any treatment
干预措施: Dietary recommendations (Other)
Study Group: Women with Polycystic Ovary Syndrome
Woen diagnosed with Polycystic Ovary Syndrome according to the Rotterdam Criteria (requires 2 out of 3 symptoms: 1. Hyperandrogenism or excess levels of androgen. 2. Oligo or anovulation. 3. Polycystic ovaries on ultrasound - over 12 follicles, 2-9 mm or increased ovarian volume),who haven't started any treatment
干预措施: Oral contraceptive pills (Drug)
Study Group: Women with Polycystic Ovary Syndrome
Woen diagnosed with Polycystic Ovary Syndrome according to the Rotterdam Criteria (requires 2 out of 3 symptoms: 1. Hyperandrogenism or excess levels of androgen. 2. Oligo or anovulation. 3. Polycystic ovaries on ultrasound - over 12 follicles, 2-9 mm or increased ovarian volume),who haven't started any treatment
干预措施: Metformin (Drug)
结局指标
主要结局
Vaginal and gut microbiota composition before and after intervention recommended and in comparison to women without PCOS.
时间窗: Through study completion, an estimated period of 1 year
Evaluated by PCR ( ng/microl)
次要结局
- Hirsutism(Through study completion, an estimated period of 1 year)
- Fertility(Through study completion, an estimated period of 1 year)
- Acne(Through study completion, an estimated period of 1 year)
研究者
Dr. Aya Mohr-Sasson
Principal Investigator
Sheba Medical Center