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临床试验/NCT05618106
NCT05618106已完成不适用

Modification of the Low FODMAP Diet in Treatment of Irritable Bowel Syndrome: A Randomised Cross-over Study

Jens Rikardt Andersen1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2019年3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
9
试验地点
1
主要终点
Birmingham IBS questionnaire and adequate relief (IBS-AR).

研究概览

简要总结

The aim was aimed to investigate if all carbohydrate groups eliminated in the Low FODMAP diet are equally important in relieving gastrointestinal symptoms in IBS.

in a randomized cross-over design to three different carbohydrate-modified diets: A) Low Polyol diet, B) Low FOS+GOS diet, and C) Low FODMAP diet for three months without wash-out-periods. Gastrointestinal symptoms, Quality of life was measured at baseline and after each intervention diet.

详细描述

Low FODMAP diets contain 3 major types of carbohydrates to be avoided. The clasical diet is very difficult to maintain over longer periods of time. Therefore, we aimed to investigate if all carbohydrate groups in the Low FODMAP diet are equally important in relieving gastrointestinal symptoms in IBS.

Patients diagnosed with IBS according to the Rome III criteria were randomised in a cross-over design to three different carbohydrate-modified diets: A) Low Polyol diet, B) Low FOS+GOS diet, and C) Low FODMAP diet for a total of three months without wash-out-periods. Gastrointestinal symptoms were assessed by the Birmingham IBS questionnaire and adequate relief (IBS-AR). Quality of life was measured by the IBS Quality of Life Scale questionnaire (IBS-QOL). All registrations were performed at baseline and after each intervention diet.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •IBS diagnosed by the Rome III criteria and
  • •referred to the clinic for treatment by diet

排除标准

  • •lack of ability to speak Danish
  • •additional chronic diseases prevailing participation

研究组 & 干预措施

low FODMAP diet

Experimental

Diet low in all kinds of FODMAPS

干预措施: Low FODMAP DIET = Diet with Low polyol, FOS and GOS (Other)

Low Fodmap diet but polyols allowed

Placebo Comparator

Diet low in FOS and GOS

干预措施: Low FODMAP DIET = Diet with Low polyol, FOS and GOS (Other)

Low Fodmap diet but FOS and GOS allowed

Active Comparator

Diet low in polyols

干预措施: Low FODMAP DIET = Diet with Low polyol, FOS and GOS (Other)

结局指标

主要结局

Birmingham IBS questionnaire and adequate relief (IBS-AR).

时间窗: 3 months

Score in points (low score means few symptoms)

次要结局

  • IBS Quality of Life Scale questionnaire (IBS-QOL)(3 months)

研究者

发起方
Jens Rikardt Andersen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jens Rikardt Andersen

Assoc Prof

University of Copenhagen

研究点 (1)

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