Acid Reflux and Stromal Fibroblasts in Barrett's Esophagus - Full Text View

Sponsors and Collaborators:	Mayo Clinic AstraZeneca
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00573911

Purpose

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

U.S. FDA Resources

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

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

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

Estimated Enrollment:	20
Study Start Date:	August 2007

Detailed Description:

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).

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00573911

Locations

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.

Sponsors and Collaborators

Mayo Clinic

AstraZeneca

Investigators

Principal Investigator:

Ganapathy A. Prasad, M.D.

Mayo Clinic

More Information

No publications provided

Responsible Party:	Mayo Clinic ( Ganapathy A. Prasad, M.D. )
Study ID Numbers:	07-002453, IRUSESOM0546
Study First Received:	December 12, 2007
Last Updated:	December 13, 2007
ClinicalTrials.gov Identifier:	NCT00573911 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Mayo Clinic:

Barrett's esophagus
GERD

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Abnormalities
Esophageal Disorder
Barrett Syndrome
Gastrointestinal Diseases

Barrett Esophagus
Esophageal Diseases
Congenital Abnormalities
Gastroesophageal Reflux

Additional relevant MeSH terms:

Digestive System Diseases
Digestive System Abnormalities
Gastrointestinal Diseases
Barrett Esophagus
Esophageal Diseases

ClinicalTrials.gov processed this record on May 07, 2009