Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00216788
Status:
UNKNOWN
Last Update Posted:
2010-03-16
First Post:
2005-09-19
Brief Title:
The Effect of Nexium on Transmucosal Esophageal Leak
Sponsor:
Main Line Health
Organization:
Main Line Health
Study Overview
Official Title:
The Effect of Proton Pump Inhibitors on Transmucosal Esophageal Leak
Status:
UNKNOWN
Status Verified Date:
2005-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In a related study the investigators have found evidence that patients with Barretts 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 Barretts esophagus andor esophagitis in a patient reporting with reflux GERD symptoms The leak is presumably in the Barretts 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 Barretts patients
Detailed Description:
In a related study we have found evidence that patients with Barretts 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 Barretts esophagus andor esophagitis in a patient reporting with reflux GERD symptoms The leak is presumably in the Barretts 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 Barretts 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 mgday 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
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 mgday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None