NCT03707002已完成不适用
Randomized, Placebo-controlled Double Blind Study to Evaluate the Effects of Dietary Supplementation With Short-chain Fructo-oligosaccharides (scFOS) on Nincrease in Stool Frequency in Constipated People
Syral2 个研究点 分布在 1 个国家目标入组 186 人开始时间: 2015年10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
- 186
- 试验地点
- 2
- 主要终点
- Stool frequency
研究概览
简要总结
The study aims to evaluate the effects of short-chain fructo-oligosaccharides on the frequency and consistency of stools in subjects with functional constipation.
详细描述
This randomized, placebo-controlled, double-blind study aims to evaluate the effects of short-chain fructo-oligosaccharides on the frequency and consistency 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Identical sachets containing 5g of scFOS or placebo (maltodextrins)
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
- 是
入选标准
- •functional constipation according to ROME III criteria with 3 or less than 3 stools per week
- •BMI between 18 and 32kg/m², limits included
- •Subjects who do not usually eat high-fibre foods
- •Subjects who do not usually consume foods siad "reduced in sugars" or "light"
- •Subjects who do not consume regularly pre- and probiotics in the form of dietary supplements
排除标准
- •subjects presenting Irritable bowel syndrome
- •history of chronic GI disorders: crohn disease, ulcerative colitis,....
- •treatments likely to influence GI sensitivity or motility (laxative, neuroleptics,...)
- •Antibiotic therapy in progress or in the past 8 weeks
- •medical history with impact on the study objectives as defined by investigator
- •known food allergy to one of the compounds of the study product
研究组 & 干预措施
scFOS
Active Comparator
scFOS consumed at 5g/day for 6 weeks
干预措施: scFOS (Dietary Supplement)
Placebo
Placebo Comparator
maltodextrin consumed at 5g/day for 6 weeks
干预措施: Maltodextrin (Dietary Supplement)
结局指标
主要结局
Stool frequency
时间窗: 6 weeks
Change in the number of stool per week between week at Baseline and the last week of supplementation
次要结局
- Anxiety and depression(6 weeks)
- Frequency and severity of Gastrointestinal symptoms(6 weeks)
- Stool consistency(6 weeks)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Effects of scFOS on Stool Frequency in People With Functionnal ConstipationFunctional ConstipationNCT01847950Syral120
已完成
不适用
Effects of follow-on Formula Enriched on Short-chain Fructooligosaccharides (scFOS) on Immune Response in Healthy InfantsInfantNCT00948051Syral60
Unknown
不适用
The Inside Study: Oligosaccharides Versus Placebo in Functional ConstipationFunctional ConstipationNCT04282551Wageningen University and Research198
招募中
不适用
Prebiotic EffecT InfanTsInfant DevelopmentHealthyDiet, HealthyNCT04791956Beneo-Institute140
Unknown
不适用
The Inside Study II: Oligosaccharides Versus Placebo and Hard StoolsHealthy With Hard and/or Lumpy StoolsNCT04295213Wageningen University and Research196