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临床试验/NCT07394920
NCT07394920尚未招募不适用

The Role of Sodium Bicarbonate Enema in Improving Constipation and Reducing Uremic Toxins in Chronic Kidney Disease Patients.

Assiut University0 个研究点目标入组 100 人开始时间: 2026年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
uremic toxins level

研究概览

简要总结

Chronic kidney disease (CKD) is a progressive condition characterized by a gradual loss of kidney function, often resulting in the accumulation of metabolic waste products. One of the emerging areas of interest in CKD management is the gut-kidney axis, which highlights the interplay between gut microbiota and renal health. CKD patients frequently exhibit gut dysbiosis and increased production of gut-derived uremic toxins such as indoxyl sulfate and p-cresyl sulfate, which can further exacerbate kidney damage and systemic inflammation.

CKD causes acidosis because damaged kidneys can't effectively excrete acids from the body or produce enough bicarbonate to neutralize them. This imbalance leads to a buildup of acids in the blood, resulting in metabolic acidosis, where acid levels in the blood become greater than normal.

Recent evidence suggests a close association between constipation and clinical outcomes such as cardiovascular disease, CKD progression and mortality(1-4). In particular, numerous observational studies have reported a higher prevalence of constipation in patients with CKD. Although the global prevalence of constipation in the general population has been estimated at approximately 14%, the prevalence in patients with CKD is reported to be much higher(5). A recent meta analysis reported a constipation prevalence of 38.8% in patients with advanced non-dialysis CKD(6). Patients with end-stage renal disease (ESRD) have been shown to have a substantially higher constipation prevalence, with some studies reporting over 50%(7).

This study focuses on using the GIT as an additional excretory pathway of the uremic toxins via using sodium bicarbonate enema in patients with CKD.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • - Adults aged 18-60 years
  • Diagnosed with CKD stage 3-4
  • Stable renal function for 3 months
  • Able to give informed consent

排除标准

  • - Active GI disease (IBD, colon cancer, severe hemorrhoids, anal fissure)
  • Recent abdominal or colorectal surgery
  • Severe cardiovascular conditions
  • Pregnancy or breastfeeding
  • Electrolyte imbalance

研究组 & 干预措施

study group

Active Comparator

patients with CKD will recived sodium bicarbonate enema

干预措施: sodium bicarbonate enema (Procedure)

结局指标

主要结局

uremic toxins level

时间窗: 3 months

uremic toxins level after sodium bicarbonate enema

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Ali Goubara Abdulhaq

residant doctor at Assiut university hospital

Assiut University

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