The Frequency of Eosinophilic Esophagitis in Patients With Heartburn That is Refractory to Proton Pump Inhibitors
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Purpose
Background: Up to 40% of patients who are treated with PPIs for symptoms that are thought to be due to GERD experience only incomplete relief of their symptoms. Those patients are deemed "PPI failures." Esophageal pH monitoring studies have shown that PPI failure rarely is due to persistent acid reflux. Recently, heartburn that is refractory to treatment with PPIs has been described in patients with eosinophilic esophagitis, a disorder of unknown etiology in which eosinophils infiltrate the squamous epithelium of the esophagus, where they cause symptoms and tissue injury. Presently, it is not clear how often eosinophilic esophagitis underlies PPI failure for patients with GERD symptoms.
Purpose: To estimate the frequency with which eosinophilic esophagitis is the cause of "PPI failure" in patients thought to have heartburn due to GERD.
Methods: Patients referred to the Division of Gastroenterology at the Dallas VA Medical Center for the evaluation of heartburn that is refractory to PPI therapy will be invited to participate in the study. Patients who provide informed consent will have a medical history taken. Women of child bearing potential will have a pregnancy test. The patients' current PPI therapy will be discontinued, and patients will be treated with lansoprazole 30 mg BID for one week. The patient will return to the clinic one week later. Patients who feel that their heartburn has not improved by more than 50% from baseline will have an endoscopic evaluation. During the endoscopic examination, biopsy specimens will be taken as follows: A. Two specimens from the proximal esophagus at 20 cm from the incisor teeth. B. Two specimens from the mid-esophagus at 28 cm from the incisor teeth. C. Two specimens from the distal esophagus, 3 cm above the squamo-columnar junction. D. Two specimens from the distal esophagus, 1 cm above the squamo-columnar junction. E. Two specimens from the second portion of the duodenum (to see if the eosinophilia is confined to the esophagus, or part of a more extensive eosinophilic gastroenteritis). A diagnosis of eosinophilic esophagitis will be made if there is at least one high-power field with >25 eosinophils, or two or more high-power fields with >15 eosinophils.
Potential Benefits: This study will provide an estimate on the frequency with which eosinophilic esophagitis is the cause of "PPI failure" in patients thought to have heartburn due to GERD. This has substantial potential importance for patient management.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastroesophageal Reflux Disease Eosinophilic Esophagitis |
Drug: Treat with lansoprazole 30 mg BID for 2 weeks, endoscopic examination with esophageal biopsy for patients with persistent symptoms |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | The Frequency of Eosinophilic Esophagitis in Patients With Heartburn That is Refractory to Proton Pump Inhibitors |
- Number of Participants With Eosinophilic Esophagitis [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Number of Patients Who Had Resolution of Heartburn With Lansoprazole [ Time Frame: After 8 weeks of treatment ] [ Designated as safety issue: No ]Resolution of heartburn defined as >50% improvement in symptoms
| Enrollment: | 102 |
| Study Start Date: | October 2007 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
-
Drug: Treat with lansoprazole 30 mg BID for 2 weeks, endoscopic examination with esophageal biopsy for patients with persistent symptoms
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:Male and female patients ages 18 years and older who are referred to the Division of Gastroenterology at the Dallas VA Medical Center for the evaluation of heartburn that is refractory to PPI therapy
Exclusion Criteria:
- Patients unwilling or unable to provide informed consent.
- Allergy to lansoprazole.
- Patients taking warfarin.
- Coagulopathy that precludes safe biopsy of the esophagus.
- Comorbidity that precludes safe participation in the study.
- Pregnancy.
Contacts and Locations| United States, Texas | |
| Dallas VA Medical Center | |
| Dallas, Texas, United States, 75216 | |
| Principal Investigator: | Stuart J Spechler, MD | Dallas VA Medical Center |
More Information
No publications provided
| Responsible Party: | Stuart Spechler, PI, Dallas VA Medical Center |
| ClinicalTrials.gov Identifier: | NCT01404832 History of Changes |
| Other Study ID Numbers: | VAIRB06-093 |
| Study First Received: | July 27, 2011 |
| Results First Received: | February 26, 2013 |
| Last Updated: | February 26, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Dallas VA Medical Center:
|
Gastroesophageal reflux Proton pump inhibitor Eosinophilic esophagitis |
Additional relevant MeSH terms:
|
Esophagitis Gastroesophageal Reflux Heartburn Eosinophilic Esophagitis Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Gastroenteritis Esophageal Motility Disorders Deglutition Disorders Signs and Symptoms, Digestive Signs and Symptoms Eosinophilia Leukocyte Disorders |
Hematologic Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Lansoprazole Proton Pump Inhibitors Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Anti-Ulcer Agents Gastrointestinal Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013