Status:
TERMINATED
Effect of Antireflux Therapy on the Expression of Genes in Patients With GERD
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
Takeda Pharmaceuticals North America, Inc.
Conditions:
GERD
Gastroesophageal Reflux
Eligibility:
All Genders
18-74 years
Brief 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 t...
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 a...
Eligibility Criteria
Inclusion
- For patients with GERD
- Patients referred for anti-reflux surgery
- On PPI therapy for at least 6 months
- Positive ambulatory pH monitoring (%time pH\<4 \> 4.7)
- Age greater than 18 years old.
- Both genders
- For non-GERD controls
- Negative ambulatory pH monitoring OR
- Upper endoscopy performed for non-GERD symptoms.
- Age greater than 18 years old.
- Both genders
Exclusion
- Prior foregut surgery
- Contra-indications for operation (poor clinical status, etc.)
- Contra-indications for endoscopy and biopsy (esophageal or gastric varices, therapeutic anticoagulation with Coumadin or Heparin, etc.)
- Unwillingness to participate in all of the follow-up studies
- Pregnancy
- Patients using medications that may interfere with PPIs pharmacokinetics (sucralfate, ketoconazole (Nizoral), ampicillin (Omnipen, Principen), digoxin (Lanoxin, Lanoxicaps), and iron (Feosol, Mol-Iron, Fergon, Femiron).
- Patients using medications that may interfere with gene expression (Immunosuppressants, Aspirin, NSAIDs, Corticosteroids).
- Patients with diseases that may interfere with gene expression (autoimmune diseases, diseases that course with immunosuppression).
Key Trial Info
Start Date :
January 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00624546
Start Date
January 1 2009
End Date
January 1 2014
Last Update
October 26 2015
Active Locations (1)
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1
Strong Memorial Hospital
Rochester, New York, United States, 14564