Evaluate the efficacy of pre & probiotic formulation for management of Endometriosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- 1. Reduction in the chronic pain and improved digestive function in women with endometriosis.
研究概览
简要总结
Endometriosis is a chronic inflammatory condition where endometrial-like tissue grows outside the uterus, affecting about 190 million women worldwide. It can cause a range of symptoms, including mood disorders and digestive issues similar to irritable bowel syndrome (IBS).
The gut microbiota, which influences immune function and inflammation, may play a role in the severity of endometriosis symptoms. Modulating gut microbiota can reduce systemic inflammation and can be beneficial for managing the symptoms associated with endometriosis in women.
Current treatments include surgery and medical therapies, highlighting the need for safe, effective prevention and management options for women of reproductive age. Regulation of gut microbiota utilizing antibiotics, fecal bacteria transplantation, probiotics, nutrients, etc., may provide new ideas for the clinical treatment of endometriosis.
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
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women aged 20-50 years with a confirmed diagnosis of endometriosis.
- •Experiencing moderate to severe endometriosis-related pain (e.g., dysmenorrhea, dyspareunia).
- •Complaints of gastrointestinal disturbances (e.g., bloating, IBS-like symptoms) related to endometriosis.
- •Stable hormonal therapy regimen for at least 3 months, if applicable.
排除标准
- •Subjects who are pregnant, have known allergies to resveratrol or contraindications to monophasic contraceptive pills, according to World Health Organization eligibility criteria.
- •Women on previous probiotic supplementation will be excluded from this study.
结局指标
主要结局
1. Reduction in the chronic pain and improved digestive function in women with endometriosis.
时间窗: At baseline and after 12 weeks
2. Effect on CA-125 a biomarker for endometriosis
时间窗: At baseline and after 12 weeks
次要结局
- Insights into the specific mechanisms by which probiotics exert their effects on(endometriosis could lead to the development of more targeted and effective treatments.)
研究者
Dr Preeti Arora
Research Division of Accurate Diagnostics Pvt. Ltd. Genomic Research and Solutions Pvt. Ltd.