Epithelial Damage in GERD | NCT01867931

Studies
Epithelial Damage in GERD

NCT01867931

Sponsor

Maastricht University Medical Center

Status

Completed

Last Update Posted

Feb 20, 2015Estimated

Enrollment

34Actual

Phase

Not provided

Conditions

Gastro-esophageal Reflux Disease

Interventions

Not provided

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

May 2014Actual

Completion Date

Oct 2014Actual

First Submitted Date

Apr 4, 2013

First Submission Date that Met QC Criteria

May 30, 2013

First Posted Date

Jun 4, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 19, 2015

Last Update Posted Date

Feb 20, 2015Estimated

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

34Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Epithelial integrity in tissue biopsies		1 year

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
J.M. Conchillo, MD PhD	Maastricht University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maastricht University Medical Center		Maastricht		6229 HX	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21448147	Background	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.
15765412	Background	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.

Label	Type	Description	Intervention Names
Erosive Esophagitis
Non-erosive Reflux Disease
Heatlhy volunteers

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases