Epithelial Damage in GERD

Completed

• Conditions: Gastro-esophageal Reflux Disease

• Registration Number: NCT01867931
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

The purpose of this study is to characterize and compare epithelial damage in patients with erosive esophagitis and non-erosive reflux disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-04
• Study First Submitted QC: 2013-05-30
• Study First Posted: 2013-06-04
• Primary Completion: 2014-05
• Study Completion: 2014-10
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-19
• Last Update Posted: 2015-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Typical GERD-symptoms lasting for more than 6 months (recurrent episodes of heartburn or acid regurgitation)
• abnormal pH-parameters (pathological acid exposure and/or symptom association)

Exclusion Criteria

• Age <18 years
• Previous esophageal or gastric surgery
• Severe esophageal motility disorder on manometry
• Histological evidence of Barrett's mucosa
• Severe co-morbidities (including cardiopulmonary disease, portal hypertension, collagen diseases, morbid obesity, coagulation disorders and co-morbidity hindering a gastroscopic procedure)
• Use of anticoagulant or immunosuppressive drugs
• Inability to stop medication that can influence the test results, like PPI, for at least 10 days before tests
• Excessive alcohol consumption (>20 units per week)
• Patients unable to give informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Epithelial integrity in tissue biopsies	1 year

Secondary Outcome Measures

Name	Time	Method
Immunohistochemical markers in tissue biopsies	1 year
Histological changes in tissue biopsies	1 year

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Netherlands