Impact of Gum Acacia on Gut-microbiota Derived Metabolites in Chronic Kidney Disease Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Mean change from baseline values of serum albumin levels
研究概览
简要总结
The aim of the study is to evaluate the impact of gum acacia on serum levels of protein-bound uremic toxins (indoxyl sulfate and p-cresyl sulfate).In addition to the evaluation of its effect on metabolic profile and disease progression in chronic kidney disease patients.
详细描述
- Ethical committee approval has been obtained from Ethics committee of Faculty of Medicine, Alexandria University.
- All participants should agree to take part in this clinical study and will provide informed consent.
- Eighty chronic kidney disease patients,will be recruited from the Kidney and Urology Center (KUC) and Alexandria main university hospital (AMUH).
The 80 participants will be randomly assigned into 2 arms.
Control arm (n=40): will be treated with standard treatment without any herbal intervention.
Intervention arm (n=40): will be treated with standard treatment in addition to gum acacia sachets. Each sachet contains 25 g of gum acacia powder to be taken on daily-basis for 3 months. 4. All patients will be submitted to :
- Full patient history and clinical examination.
- Blood withdrawal in order to conduct lab work.
- Patients demographic data will be recorded with respect to age, weight and other co-morbidities.
- Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
- Results, conclusion, discussion and recommendations will be given.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-hemodialysis CKD patients (Stage III -V)
- •Age: above 18 years
排除标准
- •Hemodialysis patients
- •Pregnancy & lactation
- •Patients recently treated with antibiotic regimen (2 - 4 weeks)
- •Malignancy
- •Inflammatory bowel disease
结局指标
主要结局
Mean change from baseline values of serum albumin levels
时间窗: 3 months
Suggested parameters include: serum albumin
Mean change from baseline values of renal profile of chronic kidney disease patients.
时间窗: 3 months
Suggested parameters include: urea, serum creatinine, uric acid, urinary Albumin to creatinine (ACR)
Percentage change from baseline scores of serum levels of suggested gut-derived protein bound uremic toxins
时间窗: 3 months
indoxyl sulfate, p-cresyl sulfate sulfate)
Mean change from baseline values of complete blood picture
时间窗: 3 months
Suggested parameters include: Haemoglobin (Hb) , White blood cells count (WCC), Platelets count (PLT)
Mean change from baseline values of serum electrolytes levels
时间窗: 3 months
Suggested parameters include: serum sodium, serum potassium, serum calcium and serum phosphorus
次要结局
- Effect of gum acacia on disease progression(3 months)
- Adverse effects of gum acacia will be also addressed through adverse effect monitoring system. monitoring system(3 months)