Clinical trial · Interventional
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
NCT04329000CI-TRIAL-00044424completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
On-demand PPI therapy is feasible for the long-term treatment of patients with Barrett's esophagus.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Esophagus | — | UNRESOLVED | — |
| Proton Pump Inhibitor | — | UNRESOLVED | — |
| Reflux | — | UNRESOLVED | — |
| Symptom | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Esomeprazole | Drug | — | UNRESOLVED |
| Esomeprazole 40mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- On-demand PPI therapy
- description
- 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.
- interventionNames
- Drug: Esomeprazole 40mg
- type
- ACTIVE_COMPARATOR
- label
- Continuous PPI therapy
- description
- The patients in this group were advised to take PPI QD continuously for 48 weeks.
- interventionNames
- Drug: Esomeprazole
Primary outcomes (3)
- measure
- Rates of progression, remaining unchanged, or regression of the distal esophageal metaplastic mucosa in both groups after 48 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (7)
- BACKGROUNDKahrilas PJ. Clinical practice. Gastroesophageal reflux disease. N Engl J Med. 2008 Oct 16;359(16):1700-7. doi: 10.1056/NEJMcp0804684. PMID 18923172
- BACKGROUNDVakil N, van Zanten SV, Kahrilas P, Dent J, Jones R; Global Consensus Group. The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol. 2006 Aug;101(8):1900-20; quiz 1943. doi: 10.1111/j.1572-0241.2006.00630.x. PMID 16928254
- BACKGROUNDAttwood SE, Lundell L, Hatlebakk JG, Eklund S, Junghard O, Galmiche JP, Ell C, Fiocca R, Lind T. Medical or surgical management of GERD patients with Barrett's esophagus: the LOTUS trial 3-year experience. J Gastrointest Surg. 2008 Oct;12(10):1646-54; discussion 1654-5. doi: 10.1007/s11605-008-0645-1. Epub 2008 Aug 16. PMID 18709511
- BACKGROUNDKastelein F, Spaander MC, Steyerberg EW, Biermann K, Valkhoff VE, Kuipers EJ, Bruno MJ; ProBar Study Group. Proton pump inhibitors reduce the risk of neoplastic progression in patients with Barrett's esophagus. Clin Gastroenterol Hepatol. 2013 Apr;11(4):382-8. doi: 10.1016/j.cgh.2012.11.014. Epub 2012 Nov 28. PMID 23200977
- BACKGROUNDLaine L, Ahnen D, McClain C, Solcia E, Walsh JH. Review article: potential gastrointestinal effects of long-term acid suppression with proton pump inhibitors. Aliment Pharmacol Ther. 2000 Jun;14(6):651-68. doi: 10.1046/j.1365-2036.2000.00768.x. PMID 10848649
- BACKGROUNDSharma P, Dent J, Armstrong D, Bergman JJ, Gossner L, Hoshihara Y, Jankowski JA, Junghard O, Lundell L, Tytgat GN, Vieth M. The development and validation of an endoscopic grading system for Barrett's esophagus: the Prague C & M criteria. Gastroenterology. 2006 Nov;131(5):1392-9. doi: 10.1053/j.gastro.2006.08.032. Epub 2006 Aug 16. PMID 17101315
- BACKGROUNDGatenby PA, Ramus JR, Caygill CP, Shepherd NA, Watson A. Relevance of the detection of intestinal metaplasia in non-dysplastic columnar-lined oesophagus. Scand J Gastroenterol. 2008;43(5):524-30. doi: 10.1080/00365520701879831.