Acid Reflux and Stromal Fibroblasts in Barrett's Esophagus
Completed · Phase 1
Conditions studied: Barrett's Esophagus, GERD
In brief
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.
Key facts
- Study ID
- NCT00573911
- Run by
- Mayo Clinic
- People needed
- 16
- Starts
- 2007-08-01
- Expected to finish
- 2011-01-01
- Last updated by the study team
- 2013-01-17
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Prior histological demonstration of Barrett's esophagus that is endoscopically visible; length of visible segment >/= 1 cms
- Absence of dysplasia on prior biopsies
- Laboratory studies:
- Prothrombin time (INR) < 1.5
- Hemoglobin > 8.0 gm/dL
- Ability to provide informed consent
You may not qualify if…
- Eastern Cooperative Oncology Group performance status 3 or 4
- Inability to tolerate endoscopic procedures
- Pregnancy: Females of child-bearing age will be screened with pregnancy test. Although none of the procedures in the study are contraindicated in pregnancy, sedation used in endoscopy can be contraindicated in early pregnancy
- Prior esophageal surgery, or cancer
Where it is running
- Mayo Clinic — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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