Comparison of gut microbiome in patients with PCOS versus Controls: A Cross-sectional study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To compare alpha diversity of gut microbiome between
研究概览
简要总结
HYPOTHESIS:There is no difference between gut microbiome of PCOS patients and healthy controls.
QUESTION: Is there a difference between gut microbiome of PCOS patients and healthy controls?
SUMMARY
PCOS affects 5 to 18 % of reproductive age women. It leads to chronic anovulation, infertility, miscarriage as well as increased risk of endometrial cancer, cardiovascular disease, type 2 diabetes mellitus, depression and anxiety.
Dysbiosis of gut microbiome (DOGMA) theory claims that altered gut microbiota is responsible for insulin resistance (IR) and chronic inflammation in PCOS. An imbalance between good and bad gut bacteria plays the key role in its pathogenesis. Several studies have shown significant differences in gut microbiota between controls and disease groups. Correlation between microbial diversity indices and metabolic/ hormonal profile has given new insights into pathology of PCOS.
Current treatment options include lifestyle changes, insulin sensitizers, sex steroids and gonadotropins have certain disadvantages. Hence, there is scope of indulging into new treatment approaches in PCOS. Modification of the colonic bacterial balance through the use of prebiotics and probiotics has the potential to be an effective treatment of PCOS, with several disadvantages over traditional treatments since it targets the proposed initial pathological insult n the condition - microbiological dysbiosis and resultant leaky gut. There is a paucity of literature regarding altered gut microbiome among patients with PCOS in western India population. Therefore, our study aims to study the gut microbial diversity and its correlation with metabolic/ hormonal profile in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)(—)
- 性别
- Female
入选标准
- •CASES: ANY FEMALE FULFILLING ROTTERDAM CRITERIA FOR DIAGNOSIS OF PCOS CONTROLS: ANY FEMALE WITH REGULAR MENSTRUAL CYCLES.
排除标准
- •1.Hyperprolactinemia 2.Thyroid dysfunction 3.Cushing’s syndrome and exogenous steroid therapy 4.Androgen-secreting tumours 5.Non classic congenital adrenal hyperplasia 6.Diabetes Mellitus 7.Patients on treatment for insulin resistance 8.Patients on treatment with oral contraceptive pills 9.Pregnant and lactating females 10.Patients who took antibiotics/ prebiotics in previous 1 month 11.Gastrointestinal disease (Ulcerative Colitis, Crohn’s disease, Malignancy, Colitis, Enteritis) 12.Patients with either acute or chronic systemic illnesses.
结局指标
主要结局
To compare alpha diversity of gut microbiome between
时间窗: at the completion of study
treatment naive PCOS patients with age and BMI matched
时间窗: at the completion of study
controls
时间窗: at the completion of study
次要结局
- To compare beta diversity indices of gut microbiome(between treatment naive PCOS patients with age & BMI)
研究者
Dr. Nikhil Bhagwat
TNMC AND NAIR HOSPITAL
