Effects of Polydextrose Supplementation on Constipation in Patients Undergoing Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 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
- 否
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
研究组 & 干预措施
polydextrose
Administration of 12g polydextrose daily for 2 months
干预措施: Polydextrose (Dietary Supplement)
Placebo Group
Administration of corn starch daily for 2 months
干预措施: Polydextrose (Dietary Supplement)
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
Denise Mafra
professor
Universidade Federal Fluminense