The Role Of Gastroesophageal Reflux Disease (GERD) in Eosinophilic Esophagitis

Last updated: January 12, 2016
Sponsor: Mayo Clinic
Overall Status: Completed

Phase

2/3

Condition

Heartburn

Esophageal Disorders

Gastroesophageal Reflux Disease (Gerd)

Treatment

N/A

Clinical Study ID

NCT00728481
07-006685
  • Ages 18-80
  • All Genders

Study Summary

The primary aim of this study was to determine the proportion of patients with esophageal eosinophilic infiltration that have objective (measurable) evidence of gastroesophageal reflux disease (GERD).

This study was also done to see if patients that have eosinophilic esophagitis (EE) and GERD would receive relief from taking the medication Nexium or a steroid called Pulmicort.

The study also evaluated the accuracy of pH monitoring (acid exposure) within the esophagus as a predictor of endoscopic, histological and symptomatic response in patients with EE.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients ages 18-80.

  2. Patients who carry the diagnosis of Eosinophilic Esophagitis (EE) based on esophagealbiopsies obtained within 18 months prior to enrollment with greater than 15eosinophils (eos) per high power field (hpf) (400 X magnification).

  3. Patients who have moderate, severe, or very severe problems swallowing.

Exclusion

Exclusion Criteria:

  1. Patients who are currently being treated for EE.

  2. Patients who have used topical or systemic corticosteroid therapy for any reason overthe past 4 weeks.

  3. Patients who have been treated with acid-suppressing medications (Proton PumpInhibitor or H2 receptor antagonists) within 4 weeks prior to enrollment.

  4. Patients with known allergies or hypersensitivity to proton-pump inhibitors orcorticosteroids.

  5. Patients who have contraindications to the procurement of biopsies including patientshow have known bleeding disorders, a history of bleeding diathesis, or who arecurrently using warfarin or clopidogrel.

  6. Patients who have a contraindication to the performance of anesophagogastroduodenoscopy (EGD) including previous cardiopulmonary arrest during anendoscopic procedure.

  7. Patients who have contraindications to the performance of ambulatory impedance 24-hourpH testing including patients with oropharyngeal abnormalities that would prohibit thesafe passage of the transnasal catheter and patients who are currently using warfarin,have a history of bleeding disorders or bleeding diatheses.

  8. Patients who are pregnant.

Study Design

Total Participants: 51
Study Start date:
May 01, 2008
Estimated Completion Date:
December 31, 2010

Study Description

Hypotheses:

  1. There is a subset of patients with the diagnosis of EE who also have GERD.

  2. Patients with both EE and GERD will respond symptomatically and histologically to aggressive gastric acid suppression with a proton pump inhibitor as monotherapy.

  3. Swallowed budesonide suspension is effective in treating patients with EE who do not have evidence of GERD.

Participants were randomized based on results of a 24 hour pH study, which determined the average percent time the distal esophagus was exposed to a pH of less than than 4. Subjects with a positive pH result were randomized to esomeprazole or randomized to budesonide, if there was a negative pH result. Studies were interpreted by a single gastroenterologist experienced in reading esophageal pH studies. The percent time the pH monitor detected a pH less than 4 was recorded and an esophageal pH of less than 4 for 4% or greater of the study time was considered abnormal. Note: pH is a measure of acidity or alkalinity (lower numbers are more acid, higher numbers are more alkaline).

Those subjects with GERD (positive pH result) received gastric acid-suppressing medication (esomeprazole 40 mg, twice daily) for 6 weeks. Subjects who did not have GERD (negative pH result) were treated with a corticosteroid designed to coat the esophagus (budesonide suspension 1 mg twice daily) for six weeks. Response to treatment was assessed by esophageal histology and symptoms.

Connect with a study center

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.