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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04329000

Enrollment

218

Registered

2020-04-01

Start date

2010-02-02

Completion date

2019-12-08

Last updated

2020-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Barrett Esophagus, Proton Pump Inhibitor, Reflux, Symptom

Keywords

Barrett's Esophagus, Erosive esophagitis, Proton pump inhibitor, On-demand therapy, Continuous therapy

Brief summary

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

Detailed description

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

Interventions

DRUGEsomeprazole 40mg

On-demand Esomeprazole 40 mg QD

DRUGEsomeprazole

Continuous Esomeprazole 40 mg QD

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Intervention model description

Randomized-controlled trial

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026