Evaluating the efficacy of Pre and Probiotics supplementation in Managing Polycystic Ovarian Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. Improvement in insulin resistance.
研究概览
简要总结
Polycystic ovary syndrome (PCOS) affects 3.6% to 15% of women of reproductive age and is linked to issues like infertility, endometrial cancer, obesity, and metabolic diseases. While the exact cause of PCOS is unknown, insulin resistance, altered gonadotropin signaling, and ovarian dysfunction are involved in its development. Recent studies show that women with PCOS have distinct gut microbiota profiles compared to healthy women, with a bidirectional relationship between gut health and PCOS features. Since gut microbiota affects insulin resistance, obesity, and inflammation—key aspects of PCOS—modulating the gut microbiome is being explored as a new treatment approach alongside traditional pharmacological and lifestyle interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 19.00 Year(s) 至 37.00 Year(s)（—）
- 性别
- Female
入选标准
- •Reproductive-aged women (19–37 years) with a confirmed diagnosis of PCOS according to the 2003 Rotterdam criteria and a body mass index (BMI) ≥ 25 kg/m2 were included.
排除标准
- •Subjects with a history of chronic diseases, including diabetes, lung, pancreatic, renal, liver, or cardiovascular disease, thyroid disorders, hyperprolactinemia, Cushing’s syndrome, autoimmune diseases, allergy to probiotic products, use of antibiotics or multivitamin-mineral supplements within the last three months, and following specific diet or physical activity programs.
结局指标
主要结局
1. Improvement in insulin resistance.
时间窗: At baseline and after 12 weeks
2. restoration of hormonal balance, with particular attention to changes in androgen levels (such as testosterone) and the luteinizing hormone (LH) to follicle-stimulating hormone (FSH) ratio, alongside other relevant reproductive hormones
时间窗: At baseline and after 12 weeks
次要结局
- impact of probiotic supplementation on clinical characteristics (BMI, Hirsutism , Menstrual irregularity)(After 12 weeks)
研究者
Dr Preeti Arora
Research Division of Accurate Diagnostics Pvt. Ltd