Functional and Molecular Characterisation of Oesophageal Distal Epithelium: Correlations With Acid and Non Acid Reflux

April 27, 2007 updated by: Nantes University Hospital
This study aims to characterize the permeability as well as some protein involved in the cell junction in the oesophageal epithelium in patients with GORD symptoms. In addition these patients will be characterized for their reflux especially by pH-impedancemetry, Bilitec and oesophageal acid perfusion test. Correlations between the characteristics of the reflux and the biological results will be calculated.

Study Overview

Status

Unknown

Conditions

Detailed Description

This study aims to characterize the permeability as well as some protein involved in the cell junction in the oesophageal epithelium in patients with GORD symptoms. In addition these patients will be characterized for their reflux especially by pH-impedancemetry, Bilitec and oesophageal acid perfusion test. Correlations between the characteristics of the reflux and the biological results will be calculated.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Stanislas Bruley des Varannes, MD
  • Phone Number: (33) 240 083 306
  • Email: bruley@easynet.fr

Study Locations

  • France
      • Nantes, France, 44093
        • Recruiting
        • Nantes university hospital
        • Contact:
          • Stanislas Bruley des Varannes, MD
          • Phone Number: (33) 240 083 306
          • Email: bruley@easynet.fr
        • Sub-Investigator:
          • JP Galmiche, MD
        • Sub-Investigator:
          • Sylvie Sacher-Huvelin, MD
        • Sub-Investigator:
          • Marc Le Rhun, MD
        • Sub-Investigator:
          • E Coron, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Main inclusion criteria :

  • Digestive symptoms suggestive of GORD (heartburn, regurgitation, epigastric pain), or dyspeptic syndrome (nausea, belch, bloating, epigastric discomfort).
  • Need of upper GI endoscopy and pH monitoring.
  • Normal propagation of oesophageal persitaltic waves (manometry < 6 months).
  • Age 18 -70 yrs
  • Signed informed consent
  • Normal coagulation

Exclusion Criteria:

  • Barrett's oesophagus
  • Previous oesophageal bleeding
  • Need of NSAID treatment.
  • Previous sus mesocolic surgery
  • Alcool consumption > 40g/d, smoking > 10 cig/j
  • Pregnancy or lack of contraceptive disposal, breast feeding.
  • Allergy to Xylocaïne

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Stanislas Bruley des Varannes, Md, Centre Hospitalier et Universitaire de Nantes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

October 3, 2005

First Submitted That Met QC Criteria

October 3, 2005

First Posted (ESTIMATE)

October 4, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

April 30, 2007

Last Update Submitted That Met QC Criteria

April 27, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRD 05-3-H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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