Role of Gastroesophageal Acid Reflux at Squamo-columnar Junction in Functional Dyspepsia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- The primary outcome measure is the proportion of patients who report positive response to adequate relief of dyspeptic symptoms at week 8.
研究概览
简要总结
Background:
Functional dyspepsia is one of the commonest 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 results on effectiveness of PPI are conflicting and it has been suggested that PPI is only effective for acid-related symptoms.
The investigators plan to use a wireless pH monitoring system positioned at the junction of esophagus and stomach to evaluate the chronological relationship between acid exposure at this region and symptoms of dyspepsia as well as its impact on the efficacy of acid suppressive therapy in treatment of functional dyspepsia.
Indication:
Functional dyspepsia patients
Study center(s):
Prince of Wales Hospital, Hong Kong
Aims:
- To evaluate the chronological relationship between acid exposure at squamo-columnar junction (SCJ) and dyspeptic symptom in different subtypes of functional dyspepsia
- To evaluate the relationship between acid exposure at squamo-columnar junction and dyspeptic symptom response to PPI
- To compare the efficacy of PPI and placebo in treating functional dyspepsia patients
Study medication:
Esomeprazole 20mg vs Placebo o.d.
Study design:
Double-blind randomized placebo-controlled trial
Number of subjects: 130
Patient population:
Functional dyspepsia patients without concomitant gastroesophageal reflux disease (GERD)
Duration of study:
1 June 2010 - 30 May 2012
Primary variable(s):
Proportion of patients who report positive response to adequate relief of dyspeptic symptoms at week 8
Secondary variable(s):
Dyspeptic symptom scores, symptom association probability of dyspeptic symptoms in relation to esophageal pH of less than 4 as measured at 1 cm above SCJ.
Number of visits: 2
Hypothesis:
Increased acid exposure at SCJ contributes to dyspeptic symptom and predicts treatment response to PPI in FD patients without concomitant GERD
详细描述
Baseline assessment:
All patients will be invited to complete self-administered questionnaires for demographics and baseline symptom assessment
- Demographics: age, gender
- Screening of functional gastrointestinal disorder based on the Rome III questionnaires
- Functional dyspepsia symptom questionnaire: an 8-item dyspeptic symptom score questionnaire using 4-point (0-3) Likert scale based on recall of the past 7 days for assessment of epigastric pain, epigastric burning, belching, bloating, postprandial fullness, early satiation, nausea and vomiting. Functional dyspepsia will be further classified into epigastric pain syndrome (EPS) and postprandial distress syndrome (PDS) according to the Rome III definitions.
- Global dyspeptic symptom assessment: a dichotomous patient-reported scale in which they are asked to give a response of either "Yes" or "No" to the inquiry "Do you have adequate relief of dyspeptic symptom over the last 7 days?"
- GERD symptom questionnaire: Patients will also be asked to report the frequency of heartburn or acid regurgitation over the last 3 months. Patients with frequency of reflux symptoms of more than twice per month are deemed to have concomitant GERD and they will be excluded from the study.
- Psychological disorder: Patient Health Questionnaire (PHQ) will be used for screening of concomitant psychological disorder such as depression and generalized anxiety disorder.
Upper endoscopy and BRAVO pH capsule insertion:
Upper endoscopy will be arranged within 2 weeks of baseline assessment in order to exclude organic pathology such as peptic ulcer, esophagitis and neoplasm. The position and morphology of gastroesophageal junction is assessed during withdrawal of endoscope after deflation of stomach at end-expiratory of the patient in left lateral body position. The morphology of gastroesophageal junction will be graded according to the "flap valve" concept. In order to avoid the confounding effect of gross anatomical disruption of gastroesophageal junction on acid exposure at SCJ, patients with grade IV disruption of gastroesophageal junction, which refers to patulous hiatus with axial displacement of SCJ, will be excluded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients with functional dyspepsia that fulfill Rome III criteria with inadequate relief of dyspeptic symptoms
- •Provision of written consent
排除标准
- •Presence of organic pathology identified by upper endoscopy or other investigations
- •Presence of sliding hiatus hernia as defined by flap valve grade IV disruption of morphology at gastro-esophageal junction
- •Concurrent medications that affect gastrointestinal motility
- •Presence of acid reflux or heartburn symptoms of more than twice a month
- •History of gastric surgery
- •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
Placebo
Identical looking placebo (once daily)
干预措施: Placebo (Other)
Esomeprazole 20mg daily
Esomeprazole 20mg daily Oral for 8 weeks
干预措施: Esomeprazole 20mg (Drug)
结局指标
主要结局
The primary outcome measure is the proportion of patients who report positive response to adequate relief of dyspeptic symptoms at week 8.
时间窗: Week 8
The proportion of patients who report positive response
次要结局
- The secondary outcome measures include dyspeptic symptom scores, symptom association probability of dyspeptic symptoms in relation to esophageal pH of less than 4 as measured at 1 cm above SCJ.(1st visit and 8 weeks)
研究者
Justin Che-Yuen Wu
Professor
Chinese University of Hong Kong