The Effect of a Low FODMAP Diet in Irritable Bowel Syndrome Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS)
研究概览
简要总结
Tertiary care IBS patients will be recruited for a prospective low FODMAP intervention study, hereby focusing on the reintroduction phase of the diet, where patients are blindly challenged with different FODMAP groups administered as powder, to be added to the strict FODMAP exclusion phase. During the screening phase of two weeks, baseline data regarding psychological, nutritional, microbial, and genetics will be collected. Predictors of treatment response (a 50-point drop on the IBS-severity scoring system (IBS-SSS) during the strict FODMAP exclusion phase of 6 weeks) will be studied with linear mixed models.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Patients are blinded during reintroduction.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are eligible for the study if all of the following criteria are met:
- •Patients with irritable bowel syndrome as per Rome IV diagnostic criteria
- •Symptom characteristics of IBS according to Rome IV criteria
- •Patients must provide witnessed written informed consent prior to any study procedures being performed
- •Patients aged between 18 and 70 years inclusive
- •Male or female patients
排除标准
- •Patients are excluded from the study if any of the following criteria are met:
- •Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for entry into the study
- •Patients with any major psychiatric disorders (including those with a major psychosomatic element to their gastrointestinal disease), depression, alcohol or substance abuse in the last 2 years
- •Patients presenting with predominant symptoms of functional dyspepsia (FD) and of gastro-oesophageal reflux disease (GERD)
- •Patients who changed their diet over the last 3 months or have previously tried the low FODMAP diet are excluded from the study.
- •Females who are pregnant or lactating are excluded from the study.
结局指标
主要结局
Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS)
时间窗: approximately 2 years
The primary endpoint is the variable used to assess the main objective, the efficacy of low FODMAP diet on gastrointestinal symptoms in IBS (focusing on the reintroduction phase). The variables used will be the symptom scores of several symptom questionnaires. Ultimately, the efficacy of the diet is based on improvement of symptom scores. Improvement is defined as a 50-point drop on the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS). In this questionnaire, each quesiton is scored from 0-100, with a maximum total score of 500. Patients reporting scores \<50 are defined as non-IBS individuals, a score from 50-175 indicated mild disease, 175-300 moderate and \>300 severe.
次要结局
未报告次要终点
研究者
Prof Dr Jan Tack
prof.dr.
Universitaire Ziekenhuizen KU Leuven