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Influence of Acid Reflux on Stromal Epithelial Interaction in Barrett's Esophagus (CR20)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01281618
Recruitment Status : Completed
First Posted : January 24, 2011
Last Update Posted : May 6, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:

The purpose of this study is to determine the association between acid reflux and cell changes in Barrett's esophagus.

Specific aim 1: To test the hypothesis that controlled acid reflux is associated with lesser degree of stromal activation.

Specific aim 2: To test the hypothesis that stromal fibroblast derived growth factors drive BE epithelial proliferation.

Condition or disease Intervention/treatment
Barrett's Esophagus Procedure: 24 hour pH study and upper endoscopy (EGD)

Study Design

Study Type : Observational
Actual Enrollment : 48 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Influence of Acid Reflux on Stromal Epithelial Interaction in Barrett's Esophagus
Study Start Date : October 2008
Primary Completion Date : June 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Those with barrett's esophagus
Those with barrett's esophagus: no dysplasia or low grade dysplasia
Procedure: 24 hour pH study and upper endoscopy (EGD)
All subjects enrolled will undergo 24 hour pH followed by EGD.

Outcome Measures

Primary Outcome Measures :
  1. activated myofibroblasts [ Time Frame: 6 months ]
    The primary end point for the study will be the proportion of patients with activated myofibroblasts (defined as positive staining for SMA and vimentin with negative staining for Desmin, in > 50% of subepithelial myofibroblasts). This primary end point will be compared between the group with controlled acid reflux and the group without acid reflux.

Biospecimen Retention:   Samples With DNA
Tissue specimens from Barrett's esophagus

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Those diagnosed with barrett's esophagus confirmed by pathology with no dysplasia or low grade dysplasia

Inclusion Criteria:

  1. Prior histological demonstration of Barrett's esophagus that is endoscopically visible; length of visible segment >/= 1 cm
  2. Absence of dysplasia or LGD on biopsies within the past 5 years
  3. Ability to provide informed consent
  4. Age between 18 years and 90 years at study entry.

Exclusion criteria:

  1. Eastern Cooperative Oncology Group performance status 3 or 4
  2. Inability to tolerate endoscopic procedures
  3. Pregnancy: Females of child-bearing age will be screened with pregnancy test.
  4. Prior esophageal surgery, or cancer
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01281618

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Institutes of Health (NIH)
More Information

Responsible Party: Prasad G. Iyer, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01281618     History of Changes
Other Study ID Numbers: 07-004899
First Posted: January 24, 2011    Key Record Dates
Last Update Posted: May 6, 2013
Last Verified: May 2013

Keywords provided by Prasad G. Iyer, Mayo Clinic:
Barrett's esophagus

Additional relevant MeSH terms:
Barrett Esophagus
Gastroesophageal Reflux
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Esophageal Motility Disorders
Deglutition Disorders