Nociceptors, Neurotrophic Factors and Cytokine Expression in Gastroesophageal Reflux Disease

Gastro-esophageal Reflux Disease Clinical Trial

Official title:

Symptomatic Gastroesophageal Reflux Disease is Associated With Increased TRPV1 and PAR2 mRNA Expression Levels in the Esophageal Mucosa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02114216
• Other study ID #: B-1211/180-003
• Status: Completed
• Phase: N/A
• First received: March 23, 2014
• Last updated: April 24, 2016
• Start date: March 2013
• Est. completion date: August 2014

Study information

• Verified date: April 2016
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Gastro-esophageal Reflux Disease
• Gastroesophageal Reflux

Intervention

Procedure:
• endoscopic mucosal biopsy
endoscopic mucosal biopsy was undertaken for every participant.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TRPV1, GDNF, and NGF mRNA Expression of Esophageal Mucosa	The primers used in real-time qPCR were designed using PrimerExpress Software V2.0 (Applied Biosystems, Foster City, CA, USA) based on sequence information from the National Center for Biotechnology Information database. Real-time qPCR was performed in triplicate by using a StepOnePlus Real-time PCR (Applied Biosystems) with SYBR Premix Ex TaqTM (Takara Bio, Shiga, Japan) according to manufacturers' instructions and protocols. Thermal cycling was performed as follows: initial denaturation at 95 °C for 10s followed by 40 cycles of 95 °C for 5 s and 60 °C for 33s. Homo b-actin was used as a reference; i.e. each sample was normalized on the basis of its b-actin content. The relative change in all target genes expression was determined by the fold-change analysis.	up to 24weeks	No
Secondary	PAR2 and IL-8 Expression of Esophageal Mucosa	The primers used in real-time qPCR were designed using PrimerExpress Software V2.0 (Applied Biosystems, Foster City, CA, USA) based on sequence information from the National Center for Biotechnology Information database. Real-time qPCR was performed in triplicate by using a StepOnePlus Real-time PCR (Applied Biosystems) with SYBR Premix Ex TaqTM (Takara Bio, Shiga, Japan) according to manufacturers' instructions and protocols. Thermal cycling was performed as follows: initial denaturation at 95 °C for 10s followed by 40 cycles of 95 °C for 5 s and 60 °C for 33s. Homo b-actin was used as a reference; i.e. each sample was normalized on the basis of its b-actin content. The relative change in all target genes expression was determined by the fold-change analysis.	up to 24weeks	No