The Effect of a Low FODMAP Diet in Functional Dyspepsia Patients With Meal Related Symptoms (Postprandial Distress Syndrome According to the Rome IV Consensus)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Improvement on gastrointestinal symptoms
研究概览
简要总结
In this study, the investigators will evaluate the FODMAP diet as an alternative treatment for functional dyspepsia and explore its effect on different aspects of the pathophysiology of FD.
详细描述
The study design starts with a baseline period of 2 weeks, includes 6 weeks of a 'strict' FODMAP diet (no blinded), followed by a 9 week 'reintroduction' phase (single blind). Based on the patients' symptom results following each of these challenges, patients will then follow the 'moderate' FODMAP diet, where the FODMAPs that did not trigger any symptoms during the challenge tests can now be consumed. Finally patients follow 2 weeks of a diet 'moderate' in FODMAP levels (no blinded). Blood and stool samples will be collected during the complete trial at several timepoints. In addition, before and after the strict diet phase a gastroscopy will be performed as well as an intragastric pressure measurement and breath test.
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
open label strict diet phase blinded participant 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 with functional dyspepsia (postprandial distress syndrome)
- •written informed consent
- •18-70 years
排除标准
- •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 irritable bowel syndrome (IBS) 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
Improvement on gastrointestinal symptoms
时间窗: 2 years
The primary endpoint is to evaluate the efficacy of low FODMAP diet on gastrointestinal symptoms in FD. Based on the LPDS questionnaire (Leuven Postprandial Distress Syndrome Score), the primary endpoint is defined. This questionnaire contains questions with a scoring system from 0 till maximum 5 with higher scores indicating higher symptom severity. An improvement of 0.5 is considered clinically meaningful.
次要结局
- Evaluation of the low FODMAP diet on IBS related symptoms(2 years)
- Evaluation of the low FODMAP diet on duodenal barrier function(2 years)
- Evaluation of the low FODMAP diet on gastric emptying(2 years)
- Evaluation of the low FODMAP diet on symptom response and quality of life(2 years)
- Evaluation of the low FODMAP diet on depression, somatization(2 years)
- Evaluation of the low FODMAP diet on gastric accommodation(2 years)
- Reintroduction period(2 years)
研究者
Prof Dr Jan Tack
Professor
Universitaire Ziekenhuizen KU Leuven