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OpenTrials
Completed

NCT Number: NCT01867931

Epithelial Damage in GERD

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

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Key information

Conditions

Gastro-esophageal Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Maastricht University Medical Center

Maastricht, 6229 HX, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Epithelial integrity in tissue biopsies

    Time frame: 1 year

Secondary outcomes

  1. Immunohistochemical markers in tissue biopsies

    Time frame: 1 year

  2. Histological changes in tissue biopsies

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 4, 2013
Registry last updated
Feb 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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