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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2007 by Nantes University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00231881
First Posted: October 4, 2005
Last Update Posted: April 30, 2007
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.
Information provided by:
Nantes University Hospital
  Purpose
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.

Condition
Gastroesophageal Reflux

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Functional and Molecular Characterisation of Oesophageal Distal Epithelium: Correlations With Acid and Non Acid Reflux

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Estimated Enrollment: 60
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  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): NCT00231881


Contacts
Contact: Stanislas Bruley Des Varannes, MD (33) 240 083 306 bruley@easynet.fr

Locations
France
Nantes University Hospital Recruiting
Nantes, France, 44093
Contact: Stanislas Bruley des Varannes, MD    (33) 240 083 306    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         
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Stanislas Bruley des Varannes, Md Centre Hospitalier et Universitaire de Nantes
  More Information

ClinicalTrials.gov Identifier: NCT00231881     History of Changes
Other Study ID Numbers: BRD 05-3-H
First Submitted: October 3, 2005
First Posted: October 4, 2005
Last Update Posted: April 30, 2007
Last Verified: April 2007

Keywords provided by Nantes University Hospital:
GORD – Oesophageal sensitivity- Oesophageal permeability

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