Acid Reflux and Stromal Fibroblasts in Barrett's Esophagus

NCT00573911 | Completed Phase 1 DMC

• 2 other identifiers: 07-002453IRUSESOM0546
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Barrett's Esophagus; GERD

Keywords

Barrett's esophagus; GERD

Outcome Measures

Primary Outcomes (1)

• The specific aim of this proposal will be: To assess the association between acid reflux and subepithelial fibroblasts in Barrett's esophagus.

  end of study

Interventions

Endoscopy and pH study PROCEDURE

endoscopy and PH study done one time

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Mayo Clinic: lead
• AstraZeneca: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Barrett Esophagus; Gastroesophageal Reflux

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Esophageal Motility Disorders; Deglutition Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Prasad G Iyer, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: December 12, 2007
• First Posted: December 14, 2007
• Study Start: August 1, 2007
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: January 17, 2013

Record last verified: 2013-01

Locations

US (1)