NCT00624546

Effect of Antireflux Therapy on the Expression of Genes in Patients With GERD

Effect of Antireflux Therapy on the Expression of Genes Known to be Important in Inflammation, Metaplasia and Neoplasia in Patients With GERD

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 24 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

Although the symptomatic and epithelial (histologic and endoscopic) response to antireflux therapy are well known and extensively studied, little is known of the genetic events occurring in response to proton pump inhibitor therapy. Preliminary data from our laboratory has shown, for example, that COX-2 expression is not only elevated in patients with gastroesophageal reflux disease but also can be correlated with pathologic esophageal acid exposure on 24 hour pH monitoring. Similar studies have suggested that antireflux surgery may normalize COX-2 gene expression. In contrast studies following ablation of dysplastic Barrett's epithelium have shown persistence of genetic changes associated with altered cellular function, despite the return of the histologic appearance to normal. Several key mediators of inflammation, metaplasia (Barrett's) and neoplasia have now been well characterized and shown to be important factors in the pathogenesis of esophageal injury. It is likely that successful antireflux therapy returns altered expression of these mediators toward normal although this hypothesis remains largely unexplored. The aim of this study is to investigate gene expression of key mediators of the spectrum of esophageal mucosal injury and the response to antireflux therapy. Hypothesis: Antireflux therapy (proton pump inhibitor and surgical fundoplication) normalizes the expression of genes known to be involved in the pathogenesis of inflammation (esophagitis), metaplasia (Barrett esophagus) and neoplasia (adenocarcinoma).

Detailed description

Aims: To determine the effects of antireflux therapy (pump inhibitor and surgical fundoplication) on gene expression of: 1. inflammation: IL-8, IFN-g, TNF-a. 2. intestinal metaplasia: CDX-1/2, MUC2 and Sonic hedgehog. 3. Neoplasia: Cox-2, VEGF, and EGFR.

Conditions

• GERD
• Gastroesophageal Reflux

Interventions

Type	Name	Description
DRUG	Prevacid Solutabs	BID Prevacid Solutabs
PROCEDURE	Antireflux surgery	Lap Nissen

Timeline

• Start date: 2009-01-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2008-02-27
• Last updated: 2015-10-26

Locations

1 site across 1 country: United States