Epithelial Damage in GERD

Gastro-esophageal Reflux Disease Clinical Trial

Official title:

Characterisation of Esophageal Epithelial Damage in Patients With Non-erosive Reflux Disease (NERD) and Erosive Esophagitis (EE): Role of Epithelial Permeability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01867931
• Other study ID #: NL39721.068.12
• Status: Completed
• Phase: N/A
• First received: April 4, 2013
• Last updated: February 19, 2015
• Start date: April 2013
• Est. completion date: October 2014

Study information

• Verified date: February 2015
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastro-esophageal Reflux Disease
• Gastroesophageal Reflux

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

Barlow WJ, Orlando RC. The pathogenesis of heartburn in nonerosive reflux disease: a unifying hypothesis. Gastroenterology. 2005 Mar;128(3):771-8. Review. — View Citation

Jovov B, Que J, Tobey NA, Djukic Z, Hogan BL, Orlando RC. Role of E-cadherin in the pathogenesis of gastroesophageal reflux disease. Am J Gastroenterol. 2011 Jun;106(6):1039-47. doi: 10.1038/ajg.2011.102. Epub 2011 Mar 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epithelial integrity in tissue biopsies		1 year	No
Secondary	Immunohistochemical markers in tissue biopsies		1 year	No
Secondary	Histological changes in tissue biopsies		1 year	No