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Epithelial Damage in GERD

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ClinicalTrials.gov Identifier: NCT01867931
Recruitment Status : Completed
First Posted : June 4, 2013
Last Update Posted : February 20, 2015
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

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

Condition or disease
Gastro-esophageal Reflux Disease

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Study Type : Observational
Actual Enrollment : 34 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Characterisation of Esophageal Epithelial Damage in Patients With Non-erosive Reflux Disease (NERD) and Erosive Esophagitis (EE): Role of Epithelial Permeability
Study Start Date : April 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

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



Primary Outcome Measures :
  1. Epithelial integrity in tissue biopsies [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Immunohistochemical markers in tissue biopsies [ Time Frame: 1 year ]
  2. Histological changes in tissue biopsies [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01867931


Locations
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Netherlands
Maastricht University Medical Center
Maastricht, Netherlands, 6229 HX
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
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Principal Investigator: J.M. Conchillo, MD PhD Maastricht University Medical Center
Publications:
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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01867931    
Other Study ID Numbers: NL39721.068.12
First Posted: June 4, 2013    Key Record Dates
Last Update Posted: February 20, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases