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Sponsors and Collaborators: |
Mayo Clinic AstraZeneca |
Information provided by: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00573911 |
Patients with Barrett's Esophagus are known to have excessive distal esophageal acid exposure comparable to patients with erosive esophagitis. A significant proportion of patients with BE who are not symptomatic on treatment continue to have persistent acid reflux. High dose esomeprazole is able to control acid reflux in patients with BE. The effect of acid reflux on Barrett's esophagus stroma is currently unknown.
It is our hypothesis that stromal fibroblast activation in Barrett's esophagus is influenced by acid reflux. The specific aim of this proposal will be: To assess the association between acid reflux and subepithelial fibroblasts in Barrett's esophagus.
Condition | Intervention | Phase |
Barrett's Esophagus GERD |
Procedure: Endoscopy and pH study |
Phase I |
MedlinePlus related topics: | GERD |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Acid Reflux and Stromal Fibroblasts in Barrett's Esophagus |
Estimated Enrollment: | 20 |
Study Start Date: | August 2007 |
We will conduct a prospective cohort study to assess the degree of stromal activation in patients with LSBE (without dysplasia) who have adequate and inadequate control of acid reflux in the distal esophagus. The study will be conducted in two phases.
Phase 1 (Pilot): 20 patients with LSBE without dysplasia will undergo endoscopy with biopsies and a 24 hour pH study on treatment. Patients will then be divided into 2 groups:
Stromal markers that will be assessed and compared between the 2 groups will include: presence of activated myofibroblasts (detected by immunohistochemistry for vimentin and smooth muscle actin).
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Laboratory studies:
Exclusion Criteria:
United States, Minnesota | |||||
Mayo Clinic | Recruiting | ||||
Rochester, Minnesota, United States, 55905 | |||||
Contact: Kelly T. Dunagan 507-255-8692 | |||||
Principal Investigator: Ganapathy A. Prasad, M.D. |
Mayo Clinic |
AstraZeneca |
Principal Investigator: | Ganapathy A. Prasad, M.D. | Mayo Clinic |
Responsible Party: | Mayo Clinic ( Ganapathy A. Prasad, M.D. ) |
Study ID Numbers: | 07-002453, IRUSESOM0546 |
First Received: | December 12, 2007 |
Last Updated: | December 13, 2007 |
ClinicalTrials.gov Identifier: | NCT00573911 |
Health Authority: | United States: Institutional Review Board |
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