Nociceptors, Neurotrophic Factors and Cytokine Expression in Gastroesophageal Reflux Disease

Seoul National University

Status: Completed

Conditions: Gastro-esophageal Reflux Disease

Treatments: Procedure: endoscopic mucosal biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT02114216

B-1211/180-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

control group

Sham Comparator group

Description:

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.

Treatment:

Procedure: endoscopic mucosal biopsy

ERD group

Active Comparator group

Description:

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.

Treatment:

Procedure: endoscopic mucosal biopsy

NERD group

Active Comparator group

Description:

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.

Treatment:

Procedure: endoscopic mucosal biopsy