On-demand PPI Therapy is Effective on Controlling Symptoms in Patients With Barrett's Esophagus.

Study Overview
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Brief Summary
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On-demand PPI therapy is feasible for the long-term treatment of patients with Barrett's esophagus.

Detailed Description
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Consecutive patients with symptomatic Barrett's esophagus are recruited and receive biopsy for esophageal metaplastic mucosa and gastric mucosa over the antrum and body during endoscopy on enrollment. The biopsy protocol for esophageal metaplastic mucosa is following Seattle protocol. GERD Q score will be conducted on enrollment. Additionally, blood sampling for CYP2C19 genotyping is also conducted on enrollment. The eligible subjects will be treated by 8-week esomeprazole, and are then randomly assigned to receive either maintenance or on-demand esomeprazole therapy (40 mg q.d.) for 40 weeks. The patients were asked to come back every four weeks for the recording of symptom days and PPI tablet consumption numbers. Follow-up endoscopy with biopsy for esophageal and gastric mucosa is performed at the end of the 48th weeks. We will compare the effects of maintenance and on-demand PPI therapy on (1) histological changes of esophageal metaplastic mucosa (2) symptom control (3) tablet consumption number

Official Title
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The Impacts of On-demand Versus Continuous Esomeprazole Therapy on the Symptom Control and Histological Changes of Metaplastic Esophageal Epithelium in Patients With Barrett's Esophagus (EsoBE) - a Multicentre Randomized Controlled Trial

Conditions
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Barrett Esophagus, Proton Pump Inhibitor, Symptom, Reflux

Intervention / Treatment
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* Drug: Esomeprazole 40mg
* Drug: Esomeprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients between the ages of 20 and 80 years having symptoms of acid regurgitation, heart burn, or feeling of acidity in the stomach having Barrett's Esophagus proven by histology confirmation length of esophageal metaplastic mucosa equal to or longer than 1 centimeter Exclusion Criteria: pregnancy, coexistence of serious concomitant illness (for example, decompensated liver cirrhosis and uremia) previous gastric surgery, allergic to esomeprazole, presence of dysplastic esophageal mucosa equivocal endoscopic diagnosis of Barrett's esophagus

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized-controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: On-demand PPI therapy<br>The patients in this group were advised to take PPI for 8 weeks continuously, followed by on-demand PPI therapy for the following 40 weeks. | Drug: Esomeprazole 40mg<br>* On-demand Esomeprazole 40 mg QD<br>* Other names: nexium 40 mg;|
| Active Comparator: Continuous PPI therapy<br>The patients in this group were advised to take PPI QD continuously for 48 weeks. | Drug: Esomeprazole<br>* Continuous Esomeprazole 40 mg QD<br>* Other names: nexium 40 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of progression, remaining unchanged, or regression of the distal esophageal metaplastic mucosa in both groups after 48 weeks | Progression, stationary, regression | 48 weeks. | 
| Total symptom day | Days with reflux symptoms | 48 weeks | 
| Number of tablets consumed | PPI tablets consumed during follow-up | 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Barrett's Esophagus, Erosive esophagitis, Proton pump inhibitor, On-demand therapy, Continuous therapy