Clinical trial · Interventional
The Effect of Nexium on Transmucosal Esophageal Leak
The Effect of Proton Pump Inhibitors on Transmucosal Esophageal Leak
- 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)
In a related study, the investigators have found evidence that patients with Barrett's esophagus have a leak for oral sucrose to leave their upper gastrointestinal tract, enter the blood, and be filtered into urine. The amount of sucrose appearing in an overnight urine sample can be used to indicate the presence of Barrett's esophagus and/or esophagitis in a patient reporting with reflux (GERD) symptoms. The leak is presumably in the Barrett's epithelium itself. This phenomenon will be used to test if a standard 8 week therapy of Nexium in a first-time-presenting GERD patient can reduce the leak as a means of assessing the efficacy of the drug in that patient. The investigators predict that Nexium will reduce leak in esophagitis but not Barrett's patients.
Conditions
Conditions (3)
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's Esophagus | — | UNRESOLVED | — |
| Esophagitis | — | UNRESOLVED | — |
| Reflux | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Esomeprazole (Nexium) 40 mg/day | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Urine sucrose level falls below 90 mg after 8 weeks of therapy
Secondary outcomes (1)
- measure
- Reduction of patient symptoms consistent with GERD
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Patients presenting to a general practitioner / internist with symptoms of GERD defined as: * Heartburn - uncomfortable, rising, burning sensation behind the breastbone * Regurgitation of gastric acid or sour contents into the mouth * Chest pain atypical for cardiac ischemia and more suggestive of GERD * Symptoms for more than three weeks with no concurrent use of PPI's or H-2 blockers during that time period * A score greater than or equal to 5 on the AstraZeneca RDQ Exclusion Criteria: * Any patients presenting with alarm symptoms (GI bleeding, dysphagia, weight loss, abdominal mass, lymphadenopathy, or recurrent vomiting) * Diabetes (type I or II) * Renal insufficiency defined as creatinine \>1.6 * Under 18 years of age * Prior surgery on esophagus, stomach or duodenum * History of gastric/duodenal ulcers * History of H. pylori * Known history of Barrett's esophagus (recruited to parallel study) * On Coumadin or Heparin therapy * Chronic upper abdominal pain more consistent with dyspepsia or other diagnoses * Noncompliant patients
References
Publications (0)
Data not yet available