Epithelial Damage in GERD

February 19, 2015 updated by: Maastricht University Medical Center

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

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands, 6229 HX
        • Maastricht University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with EE and patients with NERD referred to the GI-outpatient clinic of the University Hospital Maastricht with an indication for diagnostic gastroscopy, as well healthy volunteers will be asked to participate in the study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Erosive Esophagitis
Non-erosive Reflux Disease
Heatlhy volunteers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Epithelial integrity in tissue biopsies
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Immunohistochemical markers in tissue biopsies
Time Frame: 1 year
1 year
Histological changes in tissue biopsies
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

  • Principal Investigator: J.M. Conchillo, MD PhD, Maastricht University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ACTUAL)

May 1, 2014

Study Completion (ACTUAL)

October 1, 2014

Study Registration Dates

First Submitted

April 4, 2013

First Submitted That Met QC Criteria

May 30, 2013

First Posted (ESTIMATE)

June 4, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

February 20, 2015

Last Update Submitted That Met QC Criteria

February 19, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL39721.068.12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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