CTRI/2025/09/094113尚未招募3 期
Synergistic Effects of Probiotic Supplementation and Metformin on Inflammatory and Metabolic Biomarkers in Women With PCOS
Dr Bhuvaneswari1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2025年9月22日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Changes in serum/fecal calprotectin and acylated ghrelin levels
研究概览
简要总结
This study is an open label randomised clinical trial conducted with 138 women who has PCOS assessing the effects of metformin, probiotics and their combination in improving intestinal inflammation and metabolic regulation over 3 months. Secondary outcomes include improvements in insulin resistance, hyperandrogenism markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients aged 18-40 years meeting Rotterdam criteria for PCOS
- •Patients willing to participate.
排除标准
- •Patients with diabetes mellitus, hypo or hyperthyroidism, or Cushing syndrome, or any other conditions leading to hyperandrogenism.
- •Patients during pregnancy or lactation
- •Patients taking antibiotics, probiotics/prebiotics within 3 months or using oral proton pump inhibitors or laxatives/drugs for treatment of acne, alopecia, or hirsutism within 6 months.
- •Any patient on or started on hormonal treatment during the study period.
结局指标
主要结局
Changes in serum/fecal calprotectin and acylated ghrelin levels
时间窗: 0 month and 3 months
次要结局
- Changes in insulin resistance markers, hyperandrogenism markers(0 month and 3 months)
研究者
Dr Bhuvaneswari
All India Institute of Medical Sciences
研究点 (1)
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