Assessing esophageal function in patients with persistent GERD symptoms despite medication

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of post-prandial esophageal high-resolution impedance manometry in patients suffering from gastro-esophageal reflux disease (GERD) symptoms that persist despite proton pump inhibitor (PPI) therapy. The study aims to identify underlying causes of these persistent symptoms through various diagnostic interventions, including upper gastrointestinal endoscopy and pH-impedance monitoring. By analyzing esophageal function, the trial seeks to improve the accuracy of GERD diagnoses and tailor treatment options for affected patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient older than 18 years
* Typical symptoms of GERD (heartburn, regurgitation) at least twice a week despite PPI therapy for at least one month.
* Reflux Disease Questionnaire (RDQ) score off PPI \> 3
* Subject with health insurance

Exclusion Criteria:

* Previous esophago-gastric surgery,
* Previous history of developing esophageal or gastric tumor, esophageal stricture, or esophageal varices
* Pregnancy (assessment at V0)
* Contraindication to general anesthesia,
* Contraindications to the wireless capsule pH-monitoring: pacemakers, implantable cardiac defibrillator,
* Contraindications to HRIM: inability to tolerate nasal intubation, significant bleeding disorders for which nasal intubation is contraindicated, known esophageal obstruction is preventing the passage of the HRIM probe.
* Intolerance or allergy to one component of the test meal,
* Intolerance or allergy to PPI,
* Inability to give consent,
* Mentally unbalanced patients, under supervision or guardianship
* Decline to participate in the study,
* Participation in another study at the same time

Where it's running

• Service d'Hepato-Gastroenterologie - Hôpital Trousseau - CHU de Tours
  Chambray-lès-Tours, France Recruiting
• Service d'Hepato-Gastroenterologie - Hôpital Louis Mourier - APHP
  Colombes, France Recruiting
• Service d'Explorations Fonctionnelles Digestives - Hôpital Edouard Herriot - HCL
  Lyon, France Recruiting
• Service d'Hepato-Gastroenterologie - Hôtel Dieu - CHU de Nantes
  Nantes, France Recruiting
• Service d'Hepato-Gastroenterologie - Hôpital Haut Lévêque - CHU de Bordeaux
  Pessac, France Recruiting
• Service d'Hepato-Gastroenterologie - Hôpital Pontchaillou- CHU de Rennes
  Rennes, France Recruiting

Study contacts

• Study coordinator: Sabine ROMAN, MD
• Email: sabine.roman@chu-lyon.fr
• Phone: 4 72 11 01 36

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.