Nociceptors, Neurotrophic Factors and Cytokine Expression in Gastroesophageal Reflux Disease

NCT02114216 | Completed Results

• 1 other identifier: B-1211/180-003
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastro-esophageal Reflux Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• PAR2 and IL-8 Expression of Esophageal Mucosa

  up to 24weeks

Study Arms (3)

control group

SHAM COMPARATOR

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.

Procedure: endoscopic mucosal biopsy

ERD group

ACTIVE COMPARATOR

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.

Procedure: endoscopic mucosal biopsy

NERD group

ACTIVE COMPARATOR

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.

Procedure: endoscopic mucosal biopsy

Interventions

endoscopic mucosal biopsy PROCEDURE

endoscopic mucosal biopsy was undertaken for every participant.

ERD group; NERD group; control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Results Point of Contact

• Title: Dr. Jinjoo Kim
• Organization: Seoul National University Hospital

jjkim0727@gmail.com

82-10-6261-6483

Study Officials

• Nayoung Kim, M.D.

  Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 23, 2014
• First Posted: April 15, 2014
• Study Start: March 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: May 2, 2016
• Results First Posted: May 2, 2016

Record last verified: 2016-04

Locations

KR (1)