Evaluation of Protective Effect of Activated Charcoal and Probiotic Against Progression of Chronic Kidney Disease
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Improving of blood urea
研究概览
简要总结
Investigate the nephroprotective effect of Activated Charcoal and Probiotic in limiting the progression of renal impairment in patients with chronic kidney disease and improving of renal function test and phosphate level.
Condition or disease:
chronic kidney disease
详细描述
Chronic kidney disease (CKD) is characterized by a gradual decrease in the glomerular filtration rate (GFR) and proteinuria. CKD is a global health problem, and its incidence has been increasing. The estimated global prevalence of CKD is 8-14%. When kidney function deteriorates gradually, many metabolites accumulate in the body. These accumulated substances, termed as uremic toxins (UTs), can result in adverse pathophysiological outcomes. UTs can affect multiple organs and cause renal fibrosis, vascular calcification, anemia, peripheral arterial disease, adynamic bone disease, adipocyte dysfunction with insulin resistance, impaired immune system, and uremic pruritus.
The pathophysiological mechanisms through which UTs cause multiple organ damage are complex and not completely understood. These mechanisms may include inflammation, reactive oxidative stress, cellular transdifferentiation, impaired mitochondria function, intestinal barrier destruction, and changes in intestinal microbiota.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
None (Open Label)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with age more than 18 years old;
- •Patients with CKD;
- •Both genders will be included.
排除标准
- •Patient with age less than 18 years old;
- •Inability or rejection to take activated charcoal or probiotic;
- •Clinically unstable;
- •Pregnant;
- •Unlikely to adhere to study procedure (eg. due to cognitive limitations, severe psychiatric disorder or alcoholism).
研究组 & 干预措施
Activated charcoal
1st group
Oral activated charcoal
20 to 25 patient with CKD will receive standard care plus Activated charcoal capsule (charconut) three times dialy for six weeks.
干预措施: Activated Charcoal (Drug)
Probiotic
2nd group
Oral probiotic
20 to 25 patient with CKD will receive standard care plus Probiotic tablet twice dialy for six weeks.
干预措施: Probiotic (Dietary Supplement)
Control group
3rd group
Control group
20 to 25 patient with CKD will receive standard care only for six weeks.
干预措施: No intervention (Other)
结局指标
主要结局
Improving of blood urea
时间窗: Baseline to 6 week
The concentration of blood urea(mmol/L),dL) ) in all blood samples
Indoxyl sulfate assay
时间窗: Baseline to 6 week
The concentration of human indoxyl sulfates level by elisa technique in the subjects' blood samples
Improving of serum creatinine mg/dL
时间窗: Baseline to 6 week
The concentration of serum creatinine(mg/dL) in all blood sample
次要结局
- Nutrition status(Baseline to 6 week)
研究者
Waleed Khaild Rahman Kareem Al-kabi
Evaluation of Protective Effect of Activated Charcoal and Probiotic Against Progression of Chronic Kidney Disease
Kufa University