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Sponsors and Collaborators: |
Lankenau Institute for Medical Research AstraZeneca Sharpe Strumia Foundation Cancer Research Foundation of America |
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Information provided by: | Lankenau Institute for Medical Research |
ClinicalTrials.gov Identifier: | NCT00216788 |
In a related study, we 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. We predict that Nexium will reduce leak in esophagitis but not Barrett's patients.
Condition | Intervention | Phase |
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Reflux Esophagitis Barrett's Esophagus |
Drug: Esomeprazole (Nexium) 40 mg/day |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | The Effect of Proton Pump Inhibitors on Transmucosal Esophageal Leak |
Estimated Enrollment: | 35 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | January 2006 |
In a related study, we have found evidence that patients with Barrett's esophagus have a leak for oral sucrose to leave the lumen of their upper gastrointestinal tract, enter the blood, and be filtered into urine. Normally the disaccharide sucrose cannot leave the lumen of the gastrointestinal tract without being first hydrolyzed to glucose and fructose. Appearance of the disaccharide in the bloodstream suggests a paracellular leak of some type in the upper gastrointestinal tract. Once in the blood, sucrose is likewise not taken up or metabolized by the kidney but simply filtered into the 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. We predict that Nexium will reduce leak in esophagitis but not Barrett's patients.
In this study, patients over 18 years of age presenting with GERD symptoms to a primary care physician, will be recruited after providing informed consent. Patients will perform a sucrose leak test the evening after their recruitment by drinking a solution of 100 gms of sucrose in 200 cc of water at bedtime, then collecting an overnight urine sample (8 hrs). Within 5 days the patient will undergo an upper endoscopy exam. The patient will then begin Nexium therapy (40 mg/day of Esomeprazole) for 8 weeks, taking the dose each morning before breakfast. After 8 weeks the patient will undergo a second sucrose leak test as described above. Urine sucrose will be determined by HPLC.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients presenting to a general practitioner / internist with symptoms of GERD defined as:
Exclusion Criteria:
Contact: Daniel Lazowick, D.O. | 610-645-6555 | |
Contact: Gambril Murray, M.D. | 610-642-6990 |
United States, Pennsylvania | |
Lankenau Hospital | |
Wynnewood, Pennsylvania, United States, 19096 |
Principal Investigator: | James M Mullin, Ph.D. | Lankenau Institute for Medical Research |
Study ID Numbers: | IRUSESOM0388 |
Study First Received: | September 19, 2005 |
Last Updated: | November 14, 2005 |
ClinicalTrials.gov Identifier: | NCT00216788 |
Health Authority: | United States: Food and Drug Administration |
Sucrose Barrett's esophagus Esophagitis GERD |
Reflux Esophagus Esomeprazole |
Esophagitis Digestive System Diseases Digestive System Abnormalities Esophageal disorder Gastrointestinal Diseases |
Omeprazole Barrett Esophagus Esophageal Diseases Gastroenteritis Congenital Abnormalities |
Molecular Mechanisms of Pharmacological Action Therapeutic Uses Anti-Ulcer Agents |
Gastrointestinal Agents Enzyme Inhibitors Pharmacologic Actions |