Effect of Selenium supplementation in modulating Sarcopenia outcomes through Gut dysbiosis in Ulcerative Colitis patients
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- The study aims to establish the role of Selenium supplementation in improving sarcopenia outcomes
研究概览
简要总结
Inflammatory Bowel disease (IBD) has become a global health issue on national and international
platforms. IBD shows two main types as per its location; one is Ulcerative Colitis (UC) and the
second is Crohn’s disease (CD). UC has three stages mild, moderate, and severe. Patients suffering
from UC have a great risk of malnutrition and micronutrient deficiency such as iron, zinc, copper,
Manganese, and selenium. Selenium (Se) deficiency is a common micronutrient deficiency in UC
patients. The deficiency arises due to the competitive demand of the human body and microbiota in
UC patients for Se. Se has antioxidant properties that help reduce the severity in UC patients. Gut
dysbiosis is one of the factors of UC that appears due to a disbalance in beneficial and harmful
bacteria produced in the gut. Another hallmark of UC is sarcopenia which develops due to chronic
inflammation. In addition, sarcopenia is caused due to gut dysbiosis and micronutrient deficiency. Se
as an oral supplement can target gut dysbiosis, sarcopenia, and UC symptoms. In this study, Se as an
oral supplement will be given to patients in the form of Selenomethionine to improve the symptoms
and severity of sarcopenia by targeting gut dysbiosis in UC patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with confirmed gut dysbiosis, sarcopenia and selenium deficiency in Ulcerative colitis patients.
排除标准
- •Females, co-morbidities (heart failure, diabetes mellitus, kidney disease and COPD) and patients on other diseases medications.
结局指标
主要结局
The study aims to establish the role of Selenium supplementation in improving sarcopenia outcomes
时间窗: baseline | endpoint after 3 months
by modulating the gut dysbiosis in UC patients
时间窗: baseline | endpoint after 3 months
次要结局
- improved quality of Life(baseline)
研究者
Gurseen Rakhra
Manav Rachna International Institute of Research and Studies