跳至主要内容
临床试验/NCT02188680
NCT02188680已完成不适用

Does Irritable Bowel Syndrome Improved by Low FODMAP Diet ?

University Hospital, Rouen1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2014年1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
112
试验地点
1
主要终点
Fructose expiration rate (ppm)

研究概览

简要总结

The patients having a syndrome SII would be more intolerant in the fructose than the healthy subjects and would benefit from a fructose diet but also from the fructans which contain some fructose. The intolerance in the fructose is diagnosed thanks to a respiratory test after absorption of fructose. However, the eviction of the fructose is sometimes recommended to the patients without having realized beforehand the test of intolerance.

详细描述

The main objective is to evaluate the efficacy of the FODMAPS diet on IBS symptoms and to correlate the results with the respiratory test

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
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

入选标准

  • older than 18, patients with IBS, patients with no organic disorders, patients informed and agreed to participate

排除标准

  • patients with sclerodermia, diabetes, obesity, anorexia, colo-rectal surgery, patients with small intestinal bacterial overgrowth, pregnancy

研究组 & 干预措施

Low FODMAPS diet and positive breath testing for fructose

Active Comparator

Patients with breath testing positive have a low FODMAPS diet. The test will be considered as positive if we observe an increase of more than 20 ppm of H2 and/or CH4 on a sample with regard to the basal concentration

干预措施: Low FODMAPS diet (Other)

negative breath testing for fructose

Sham Comparator

patients with negative breath test have a low FODMAPS diet

干预措施: Low FODMAPS diet (Other)

结局指标

主要结局

Fructose expiration rate (ppm)

时间窗: Day 15

Estimate the value of the fructose test to predict the efficiency of a diet excluding the fructose and its by-products on the digestive symptoms of the patients having a Syndrome of the irritable bowel.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Rouen
申办方类型
Other
责任方
Sponsor

研究点 (1)

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