GERD reflux disease
Conditions
Interventions
None listed
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
Exclusion criteria: GERD PATIENTS Exclusion-criteria: 1) Age 20 units per week);HEALTHY VOLUNTEERS Exclusion-criteria: 1) Age 20 units per week)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hypothesis: NERD and EE patients show lower electrical resistance over the tissue and an increased epithelial permeability. No significant differences will be seen when comparing NERD patients and patients with EE. Primary objective: • To asses epithelial integrity in biopsies of esophageal epithelium in NERD and EE patients and healthy controls as measured by the electrical resistance of the tissue in the Ussing chamber system. Primary endpoint: • Integrity of esophageal epithelium (transepithelial electrical resistance and permeability) as measured with the Ussing chamber system. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objective: • To assess the epithelial permeability using FITC-dextran permeability marker in the Ussing chamber. • To explore whether the histological hallmark of intercellular space diameter of esophageal epithelium can discriminate both NERD and EE patients from controls using the gold standard electron microscopy. • To evaluate immunohistochemical markers of esophageal epithelium damage (tight- and adherence junction proteins) in biopsies of NERD and EE patients. Secondary endpoints: • Serosal concentration of the permeability marker FITC-dextran as measured in the Ussing chamber system • Histological patterns of esophageal epithelium in NERD and EE patients as measured with transmission electron microscopy (diameter and volume of dilated intercellular spaces, basal cell hyperplasia, papillary elongation, infiltration of eosinophils, mast cell degranulation) • Immunohistochemical markers of esophageal epithelium damage in NERD and EE patients (staining of tight- and adherence junction proteins, e.g.; claudin, occludin, ZO-1, JAM, desmoglein, E-cadherin). | — |
Countries
Netherlands
Outcome results
None listed