Effect of Proton Pump Inhibitor on Gastric Emptying and Satiety Function in Patients With Functional Dyspepsia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 155
- 试验地点
- 1
- 主要终点
- gastric emptying rate as measured by BreathID:Area-under-curve (AUC) values at different time points and half-emptying time (t1/2) after 8 weeks of treatment will be used as measures for gastric emptying rate
研究概览
简要总结
Functional dyspepsia is one of the most common digestive disorders. The pathophysiology of functional dyspepsia is uncertain. Proton pump inhibitor (PPI) has been recommended as the first line treatment for functional dyspepsia. However, the mechanism of symptom relief is unclear. Most of the previous studies were performed on healthy volunteers who received only a very short course of PPI. The correlation between symptom and gastric emptying is lacking in these studies.
Demographic data and anthropometric measurements will be obtained for baseline assessment. Patients are required to complete FGI Screening Questionnaire, Functional dyspepsia symptom questionnaire, gastroesophageal reflux disease (GERD) symptom questionnaire and irritable bowel syndrome (IBS) symptom questionnaire to have a thorough assessment of their GI symptoms. (1) Satiety test and ghrelin profile, and (2)gastric emptying test will be arranged as two individual visits.
After baseline investigations, patients will be randomly assigned to either Nexium 20 mg daily or identical looking placebo for 8 weeks. The patients will report their individual dyspeptic symptoms on weekly basis using a self-administered symptom questionnaire.
Satiety test and ghrelin profile, gastric emptying study will be repeated at the end of 8-week treatment.
Hypothesis: Long-term PPI relieves dyspeptic symptom through acceleration of gastric emptying rate.
详细描述
Background
Functional dyspepsia is one of the commonest digestive disorders. It is a functional gastrointestinal disorder which is characterized by chronic recurrent epigastric symptoms such as pain, burning and a variety of postprandial symptoms with absence of demonstrable organic pathology identified on investigations. It has been reported that functional dyspepsia affects 10-30% of adult population.
The pathophysiology of functional dyspepsia is uncertain. It is thought to be a heterogeneous disorder. Various factors have been implicated in the pathophysiology of functional dyspepsia. It has been reported that delayed gastric emptying, impaired proximal gastric accommodation, visceral hypersensitivity and Helicobacter pylori gastritis play a role in development of functional dyspepsia. However, the correlation between these physiological abnormalities and symptomatology of functional dyspepsia is poor. It is still controversial whether these pathophysiological factors are responsible for specific symptoms in functional dyspepsia.
While mechanism of functional dyspepsia is unclear, treatment has also been far from satisfactory. Proton pump inhibitor has been recommended as the first line treatment for functional dyspepsia and it has been shown that the use of PPI is associated with a 14% reduction in risk of persistent dyspepsia compared to placebo. However, the mechanism of symptom relief is unclear. While PPI exerts its effect primarily through suppression of acid-induced symptoms, recent studies have shown that PPI may affect gastric motility function such as gastric volume, gastric emptying and trigger of migratory motor complex. Most of these studies were performed on healthy volunteers who received only a very short course of PPI. The correlation between symptom and gastric emptying is lacking in these studies.
Aims
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with functional dyspepsia that fulfill Rome III criteria attending GI clinic or endoscopy center
- •Age 18-60 years old
- •Provision of written consent
- •Negative upper endoscopy (oesophagogastroduodenoscopy or OGD) finding
排除标准
- •Diabetes mellitis
- •Frequent (once or more per week) acid reflux or heartburn symptoms
- •Concurrent medications that affect GI motility
- •Concurrent use of TCA
- •History of gastric surgery
- •Organic disease as cause of dyspepsia
- •H. pylori infection
- •Use of PPI or NSAID in the past 4 weeks
- •Pregnancy
- •Known hypersensitivity to PPI
研究组 & 干预措施
PPI
干预措施: Esomeprazole (Drug)
Control
干预措施: Placebo (Drug)
结局指标
主要结局
gastric emptying rate as measured by BreathID:Area-under-curve (AUC) values at different time points and half-emptying time (t1/2) after 8 weeks of treatment will be used as measures for gastric emptying rate
时间窗: 8 weeks
次要结局
- rate of adequate relief using global symptom assessment(8 weeks)
- symptom scores(8 weeks)
- calorie intake in satiety test(8 weeks)
研究者
Justin Che-Yuen Wu
Professor
Chinese University of Hong Kong