Effect of Antireflux Therapy on the Expression of Genes in Patients With GERD
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|ClinicalTrials.gov Identifier: NCT00624546|
Recruitment Status : Terminated (Expected recruitment numbers have not been achieved.)
First Posted : February 27, 2008
Last Update Posted : October 26, 2015
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).
|Condition or disease||Intervention/treatment|
|GERD Gastroesophageal Reflux||Drug: Prevacid Solutabs Procedure: Antireflux surgery|
Aims: To determine the effects of antireflux therapy (pump inhibitor and surgical fundoplication) on gene expression of:
- inflammation: IL-8, IFN-g, TNF-a.
- intestinal metaplasia: CDX-1/2, MUC2 and Sonic hedgehog.
- Neoplasia: Cox-2, VEGF, and EGFR.
|Study Type :||Observational|
|Actual Enrollment :||24 participants|
|Official Title:||Effect of Antireflux Therapy on the Expression of Genes Known to be Important in Inflammation, Metaplasia and Neoplasia in Patients With GERD|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2014|
Drug: Prevacid Solutabs
BID Prevacid Solutabs
Procedure: Antireflux surgery
non gerd controls
- gene expression [ Time Frame: before and after treatment ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00624546
|United States, New York|
|Strong Memorial Hospital|
|Rochester, New York, United States, 14564|
|Principal Investigator:||Jeffrey H Peters||University of Rochester|