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NCT00231881 Clinical Trial

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

Gastroesophageal Reflux Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00231881
Other study ID # BRD 05-3-H
Secondary ID
Status Recruiting
Phase N/A
First received October 3, 2005
Last updated April 27, 2007

Study information
Verified date April 2007
Source Nantes University Hospital
Contact Stanislas Bruley Des Varannes, MD
Phone (33) 240 083 306
Email bruley@easynet.fr
Is FDA regulated No
Health authority France : Direction Générale de la Santé (DGS)
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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 Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Locations
Country Name City State
France Nantes University Hospital Nantes

Sponsors (1)
Lead Sponsor Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

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