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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 because the information has not been verified recently.
Verified April 2007 by Nantes University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00231881
First received: October 3, 2005
Last updated: April 27, 2007
Last verified: April 2007
History of Changes
  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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00231881     History of Changes
Other Study ID Numbers: BRD 05-3-H
Study First Received: October 3, 2005
Last Updated: April 27, 2007
Health Authority: France : Direction Générale de la Santé (DGS)

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

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

ClinicalTrials.gov processed this record on May 19, 2013