Effect of Probiotic Supplementation on Resistant Anaemia to Erythropoietin in Chronic Kidney Disease Patients.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- - Hemoglobin concentration
研究概览
简要总结
The goal of this clinical trial is to assess whether probiotic supplementation can improve the hematological response of CKD patients to erythropoietin therapy and prevent or reduce erythropoietin resistance. The main questions it aims to answer are:
Can probiotic be used as an adjuvant strategy in anemia management and increasing ESA responsiveness in CKD? What medical problems do participants have when taking probiotic? Researchers will compare Erythropoietin only with Erythropoietin + Probiotic to see if Probiotic aids in treating anaemic chronic kidney disease patients.
Participants will:
Take Erythropoietin + Probiotic or Probiotic only every day for 3 months Visit the clinic once every 4 weeks for checkups and tests Keep a diary of their symptoms
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with end stage renal disease for more than 3 months on regular hemodialysis (GFR less than 15 ml/min/m2
- •Receiving stable doses of erythropoietin therapy
- •Able and willing to provide informed consent
排除标准
- •Recent probiotic, antibiotic, or immunosuppressive therapy
- •Microcytic hypochromic anemia.
- •Patients with hyperparathyroidism
- •Recent or planned kidney transplantation Gastrointestinal disorders (active IBD, cancer)
- •Pregnancy or lactation
- •Severe comorbidities (e.g., active infection, malignancies)
- •Cognitive or physical inability to comply with protocol
研究组 & 干预措施
EPO + Probiotic
EPO (4000 IU) + Probiotic (Lactobacillus acidophilus, 5 billion)
干预措施: Erythropoietin + Probiotic (Drug)
EPO
Erythropoietin (Epoetin 4000 IU)
干预措施: EPO (Drug)
结局指标
主要结局
- Hemoglobin concentration
时间窗: at baseline, and 3-months postintervention
\- Hemoglobin concentration (g/dL)at 2 weeks, and 3-months postoperatively
- Erythropoietin resistance index (ERI)
时间窗: at baseline, and 3-months postintervention
\- ERI = (ESA dose per week) / (body weight) / (hemoglobin level).
次要结局
- C-reactive protein(at baseline, and 3-months postintervention)
- serum urea(at baseline, and 3-months postintervention)
研究者
Eman Said Sawan
Lecturer
Badr University