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临床试验/NCT05336305
NCT05336305已完成不适用

Effects of Polydextrose Supplementation on Constipation in Patients Undergoing Hemodialysis

Universidade Federal Fluminense2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年3月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Change constipation status after supplementation with polydextrose

研究概览

简要总结

Constipation is a common complication in patients with chronic kidney disease (CKD), especially in hemodialysis (HD) patients. Reduced intake of fibre-rich food is among the most important causes of constipation. The study aims to investigate the possible influence of polydextrose (PDX) supplementation on constipation in patients with CKD on HD.

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 (Participant)

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

入选标准

  • Clinical diagnosis of Chronic Kidney Disease
  • Hemodialysis patients for more than 6 months
  • Aged 18 years or older

排除标准

  • Patients pregnant
  • Using antibiotics in the last 3 months
  • Autoimmune diseases
  • Clinical diagnosis of infectious diseases
  • Clinical diagnosis of Cancer
  • Clinical diagnosis of AIDS

结局指标

主要结局

Change constipation status after supplementation with polydextrose

时间窗: 2 months

Stool frequency and Bristol Stool Form

Change in cytokines plasma levels measured by ELISA after supplementation with polydextrose

时间窗: 2 months

cytokines levels

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

Denise Mafra

professor

Universidade Federal Fluminense

研究点 (2)

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