Characterisation of esophageal epithelial damage in patients with non-erosive reflux disease (NERD) and erosive esophagitis (EE): role of epithelial permeability

Completed

• Conditions: GERD; reflux disease; 10017969

• Registration Number: NL-OMON37810
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2014-09-15
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 35

Inclusion Criteria

GERD PATIENTS
Inclusie criteria:
Patients with typical GERD-symptoms lasting for more than 6 months (recurrent episodes of heartburn or acid regurgitation) and abnormal pH-parameters (pathological acid exposure and/or symptom association) or a positive response to PPI-therapy will be included. ;HEALTHY VOLUNTEERS
Inclusion criterium: No history of gastrointestinal disease, especially gastroesophageal reflux.

Exclusion Criteria

GERD PATIENTS
Exclusion-criteria:
1) Age <18 years
2) Previous esophageal or gastric surgery
3) Severe esophageal motility disorder on manometry
4) Histological evidence of Barrett*s mucosa
5) Severe co-morbidities (including cardiopulmonary disease, portal hypertension,collagen diseases, morbid obesity, coagulation disorders and co-morbidity hindering a gastroscopic procedure)
6) Use of anticoagulant or immunosuppressive drugs
7) Inability to stop medication that can influence the test results, like PPI, for at least 1 week before tests
8) Patients unable to give informed consent.
9) Excessive alcohol consumption (>20 units per week);HEALTHY VOLUNTEERS
Exclusion-criteria:
1) Age <18 years
2) Co-morbidities (including cardiopulmonary disease, collagen diseases, obesity, coagulation disorders and co-morbidity hindering a gastroscopic procedure)
3) Inability to stop medication that can influence the test results, like PPI, for at least 1 week before tests
4) Subjects unable to give informed consent.
5) Excessive alcohol consumption (>20 units per week)

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Hypothesis:<br /><br>NERD and EE patients show lower electrical resistance over the tissue and an<br /><br>increased epithelial permeability. No significant differences will be seen<br /><br>when comparing NERD patients and patients with EE.<br /><br><br /><br>Primary objective:<br /><br>• To asses epithelial integrity in biopsies of esophageal epithelium in NERD<br /><br>and EE patients and healthy controls as measured by the electrical resistance<br /><br>of the tissue in the Ussing chamber system.<br /><br><br /><br>Primary endpoint:<br /><br>• Integrity of esophageal epithelium (transepithelial electrical resistance and<br /><br>permeability) as measured with the Ussing chamber system.</p><br>