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临床试验/NCT01847950
NCT01847950已完成不适用

Randomized, Placebo-controlled Double-blind Study to Evaluate the Effects of Fructo-oligosachharides on Increase of Stool Frequency in Constipated People

Syral2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2012年11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
已完成
发起方
入组人数
120
试验地点
2
主要终点
Frequency of stool emission

研究概览

简要总结

The study aims to evaluate the effects of short-chain fructo-oligosaccharides on the frequency and constistency of stools in subjects with functional constipation

研究设计

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

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

  • subjects with functional constipation

排除标准

  • subjects treated with laxative treatments
  • subjects consuming more than 25g/day of dietary fibres
  • pregnant women

研究组 & 干预措施

short-chain fructo-oligosaccharides

Experimental

Short-chain fructo-oligosaccharides are consummed at 5g/day for 6 weeks

干预措施: Short-chain fructo-oligosaccharides (Dietary Supplement)

Maltodextrin

Placebo Comparator

maltodextrins are consummed at 5g/day for 6 weeks

干预措施: Maltodextrin (Dietary Supplement)

结局指标

主要结局

Frequency of stool emission

时间窗: 6 weeks

次要结局

  • Stool consistency (Bristol scale)(6 weeks)

研究者

发起方
Syral
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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