A Phase 1 interventional study of Endoscopy and pH study in Barrett's Esophagus and GERD, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-01-17.
Sponsored by Mayo Clinic · Phase 1, Interventional, and Diagnostic
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.
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).
310 studies on the registry are indexed under Barrett Esophagus; 64 are open to participants now.
This study's enrollment of 16 is below the median of 62 across 186 interventional studies indexed under Barrett Esophagus.
Browse Barrett Esophagus studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Laboratory studies:
Exclusion Criteria:
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
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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