NCT00231881

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 4, 2005

Completed
Last Updated

April 30, 2007

Status Verified

April 1, 2007

First QC Date

October 3, 2005

Last Update Submit

April 27, 2007

Conditions

Gastroesophageal Reflux

Keywords

GORD - Oesophageal sensitivity- Oesophageal permeability

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Stanislas Bruley des Varannes, Md

    Centre Hospitalier et Universitaire de Nantes

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stanislas Bruley Des Varannes, MD

CONTACT

(33) 240 083 306bruley@easynet.fr

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 3, 2005

First Posted

October 4, 2005

Last Updated

April 30, 2007

Record last verified: 2007-04

Locations

FR(1)