Gastric Functions & Proton Pump Inhibitor( PPI) Study

• Status: Completed
• Trial end date: 2016-02-19
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese University of Hong Kong
• Treatments: Esomeprazole; Proton Pump Inhibitors

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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