Epithelial Damage in GERD

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01867931

Enrollment

Registered

2013-06-04

Start date

2013-04-30

Completion date

2014-10-31

Last updated

2015-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastro-esophageal Reflux Disease

Brief summary

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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Epithelial integrity in tissue biopsies	1 year

Secondary

Measure	Time frame
Immunohistochemical markers in tissue biopsies	1 year
Histological changes in tissue biopsies	1 year

Countries

Netherlands

Outcome results