Randomized Controlled Study of Low-FODMAP Diet in Patients With GERD Refractory to Protons Pump Inhibitors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 10
- 主要终点
- Percentage of patients with clinical remission as defined by a RDQ score ≤ 3
研究概览
简要总结
The aim of this study is to determine the effects of a low Fermentescible Oligosaccharides Disaccharides Monosaccharides and Polyols (FODMAP) diet in patients with documented refractory GERD on proton pump inhibitor (PPI) therapy.
详细描述
Colonic fermentation has been shown to influence oeso-gastric motility : increased gastric relaxation, increased rate of lower esophageal sphincter relaxation. Experimental increased colonic fermentation (FOS in diet) increase the occurrence of reflux events in patients with GERD. The aim of this study is to compare the low-FODMAP diet and classical GERD dietary recommendations (avoid fatty meals, head of bed elevation etc..) in patients with refractory GERD symptoms.
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
- 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
- •Age > 18
- •Affiliation to French Social Security
- •Informed written consent
- •RDQ score > 3
- •Abnormal pH-impedance monitoring on PPI twice daily (since 3 months) according to normal values published by Zerbib et al (CGH 2013)
排除标准
- •Pregnancy or breast feeding
- •Women of childbearing potential without an effective method of contraception
- •Person under guardianship
- •History of thoracic of abdominal surgery (excepted appendectomy and cholecystectomy)
研究组 & 干预措施
Low-FODMAP diet
FOS in diet
干预措施: Low-FODMAP diet (Dietary Supplement)
Classical GERD diet
avoid fatty meals, head of bed elevation...
干预措施: GERD diet (Dietary Supplement)
结局指标
主要结局
Percentage of patients with clinical remission as defined by a RDQ score ≤ 3
时间窗: at Week 4 of diet
次要结局
- Between-group comparison of efficacy(at Week 4 of diet)