Nociceptors, Neurotrophic Factors and Cytokine Expression in Gastroesophageal Reflux Disease

NCT ID: NCT02114216

Last Updated: 2016-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-08-31

Brief Summary

Transient receptor potential vanilloid-1 (TRPV1) receptor and proteinase-activated receptor 2 (PAR2) have been implicated in the mechanism of acid induced inflammation in gastroesophageal reflux disease (GERD). We aimed to evaluate TRPV1 and PAR2 mRNA expression levels in the GERD patients and their relationship with endoscopic findings and reflux symptoms.

Detailed Description

All the subjects receive upper GI endoscopy and completed questionnaires about GERD symptoms under the supervision of a well-trained interviewer. Subjects are excluded if there was a history of gastrointestinal surgery, Barrett's esophagus, esophageal motility disorder, duodenal ulcer, benign gastric ulcer or gastroduodenal cancer and if he or she had any history of systemic disease requiring chronic medication (except for hypertension and diabetes mellitus).

The subjects are classified into 3 groups after upper GI endoscopy and completing questionnaires about GERDsymptoms ; ERD(erosive reflux disease), NERD(nonerosive reflux disease) and control group.

Conditions

Gastro-esophageal Reflux Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

control group

Subjects who do not show mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and do not complain of GERD symptoms. Endoscopic mucosal biopsy was done for every subject.

Group Type: SHAM_COMPARATOR

endoscopic mucosal biopsy

Intervention Type: PROCEDURE

endoscopic mucosal biopsy was undertaken for every participant.

ERD group

Subjects who have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and/or complain of GERD symptoms. Endoscopic mucosal biopsy was done for every subject.

Group Type: ACTIVE_COMPARATOR

endoscopic mucosal biopsy

Intervention Type: PROCEDURE

endoscopic mucosal biopsy was undertaken for every participant.

NERD group

Subjects who do not have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and complain of GERD symptoms. Endoscopic mucosal biopsy was done for every subject.

Group Type: ACTIVE_COMPARATOR

endoscopic mucosal biopsy

Intervention Type: PROCEDURE

endoscopic mucosal biopsy was undertaken for every participant.

Interventions

endoscopic mucosal biopsy

endoscopic mucosal biopsy was undertaken for every participant.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• subjects who completed upper GI endoscopy and questionnaires about GERD symptoms

Exclusion Criteria

• a history of gastrointestinal surgery
• Barrett's esophagus
• esophageal motility disorder
• duodenal ulcer
• benign gastric ulcer
• gastroduodenal cancer
• if he or she had any history of systemic disease requiring chronic medication (except for hypertension and diabetes mellitus).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Seoul National University Bundang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nayoung Kim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nayoung Kim, M.D.

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

B-1211/180-003

Identifier Type: -

Identifier Source: org_study_id