Acid Reflux and Stromal Fibroblasts in Barrett's Esophagus
|ClinicalTrials.gov Identifier: NCT00573911|
Recruitment Status : Completed
First Posted : December 14, 2007
Last Update Posted : January 17, 2013
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 or disease||Intervention/treatment||Phase|
|Barrett's Esophagus GERD||Procedure: Endoscopy and pH study||Phase 1|
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:
- Group A (GER): Those with ongoing acid reflux (characterized by either presence of esophagitis [LA classification B,C or D1] on endoscopy, and/or a positive pH study on treatment defined using standard criteria)
- Group B (NGER): Those with controlled acid reflux (negative endoscopy and pH study on treatment).
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Acid Reflux and Stromal Fibroblasts in Barrett's Esophagus|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||January 2011|
- Procedure: Endoscopy and pH study
endoscopy and PH study done one time
- The specific aim of this proposal will be: To assess the association between acid reflux and subepithelial fibroblasts in Barrett's esophagus. [ Time Frame: end of study ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00573911
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Prasad G Iyer, M.D.||Mayo Clinic|