In vivo evaluation of esophageal mucosal permeability in patients with non erosive reflux disease

• Conditions: Gastro-esophageal reflux disease (GERD); heartburn; 10017977

• Registration Number: NL-OMON32964
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Patients:
- Age 18 * 75 years
- Written informed consent
Healthy volunteers:
- Age 18 * 75 years
- Written informed consent

Exclusion Criteria

Patients:
- Surgery of the GE-tract other than appendectomy
- Use of PPI, or other medication influencing gastric or GI motility
- patients unable to undergo endoscopy
- Allergy to fluoresceine, midazolam, buscopan
- Renal insuffiency
Healthy volunteers:
- Surgery of the GE-tract other than appendectomy
- Gastro-intestinal complaints, including typical GERD complaints
- Medication influencing gastric motility or GI motility
- Allergy to fluoresceine, midazolam, buscopan
- Renal insuffiency

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome parameter is the permeability as measusered by fluorescein<br /><br>diffusion. It is measured by the identifiable layers of epithelium after<br /><br>certain times of spraying.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome variables:<br /><br>- permeability, as measured in vitro in ussing chambers<br /><br>- expression of tight junction proteins<br /><br>- occurence of dilated intercellular spaces</p><br>