Epithelial Damage in GERD

NCT ID: NCT01867931

Last Updated: 2015-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-10-31

Brief Summary

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

Detailed Description

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Conditions

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Gastro-esophageal Reflux Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Erosive Esophagitis

No interventions assigned to this group

Non-erosive Reflux Disease

No interventions assigned to this group

Heatlhy volunteers

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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J.M. Conchillo, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

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Maastricht University Medical Center

Maastricht, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type BACKGROUND
PMID: 21448147 (View on PubMed)

Barlow WJ, Orlando RC. The pathogenesis of heartburn in nonerosive reflux disease: a unifying hypothesis. Gastroenterology. 2005 Mar;128(3):771-8. doi: 10.1053/j.gastro.2004.08.014.

Reference Type BACKGROUND
PMID: 15765412 (View on PubMed)

Other Identifiers

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NL39721.068.12

Identifier Type: -

Identifier Source: org_study_id

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