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临床试验/NCT01076426
NCT01076426Unknown4 期

The Clinical Use of Probiotics in the Uremia Patients Under Chronic Peritoneal Dialysis

National Cheng-Kung University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2010年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
100
试验地点
1
主要终点
peritonitis rate

研究概览

简要总结

The purpose of this study is to determine whether probiotics can improve the nutrition status and prevent peritonitis in the chronic peritoneal dialysis patients.

详细描述

Peritoneal dialysis was one of therapies for uremia patient. However, peritoneal dialysis related peritonitis was a major complication for these patients. Severe and prolong peritonitis may led to membrane failure and drop out of peritoneal dialysis. Among the pathogens, G(+) bacteria came from skin surface and G(-) bacteria came from gastrointestinal tract. The later might be related to the pathogens in the gastrointestinal tract, and led to peritonitis if constipation or diarrhea developed. In addition, intestinal pathogens may be related to chronic inflammation in uremia patients. There was a MIA syndrome (malnutrition, inflammation and atherosclerosis) noted before, and chronic inflammation may be related to malnutrition. Today, we know that nutrition status and inflammation marker (CRP) may be associated with patients' outcome. Many gastrointestinal syndromes such as constipation suffer our patients. The dialysate in the abdominal cavity may further exacerbate the appetite. The probiotics was though to improve the pathogens in intestinal tract, improve gastrointestinal function. We want to decrease the incidence of peritonitis by using the probiotics. In addition, the improvement in gastrointestinal function can increase the nutrition status.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
16 Years 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • uremia patient under chronic peritoneal dialysis ≧ 3 months
  • Age between 16 and 75 years

排除标准

  • uremia patient with advanced malignance disease
  • uremia patient had more than 2 episode of G(+) peritonitis within the last one year
  • uremia patient with expected life ≦ 1 years
  • uremia patient with the history of drug or alcohol abuse
  • uremia patient with poor drug compliance
  • uremia patient with active infection disease
  • uremia patient with uncontrolled autoimmune disease such as SLE

研究组 & 干预措施

Probiotics

Experimental

probiotics treatment

干预措施: Pro-biotics (Drug)

Placebo

Placebo Comparator

干预措施: Oligosaccharide (Dietary Supplement)

结局指标

主要结局

peritonitis rate

时间窗: one year

nutrition status

时间窗: 3, 6, 9, 12 months

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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