The failure of Proton Pump Inhibitors in Gastro Esophageal Reflux Disease

Conditions: GERD
heartburn
10017977

Registration Number: NL-OMON35604

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 24

Inclusion Criteria

GERD patients with good symptom response to PPI:
- Written informed consent
- 18-75 years
- PPI use of 1-2 daily 40 mg of Omeprazole, Esomeprazole or pantoprazole, or 1-2 daily 30 mg of lansoprazole.
- GERD confirmed by pH-impedance (ph<4 in > 4,5 % of time or positive symptom association), or in patients with reflux esophagitis.;GERD patients with bad symptom response to PPI:
- Written informed consent
- 18-65 years
- PPI use of 1-2 daily 40 mg of Omeprazole, Esomeprazole or pantoprazole, or 1-2 daily 30 mg of lansoprazole.
- GERD confirmed by pH-impedance during medication, with a positive symptom association between reflux episodes and symptoms (Symptom Index >50%, or a Symptom Association Probability >95%).

Exclusion Criteria

- surgery of the gastrointestinal tract other then appendectomy
- inability to stop the use of proton pump inhibitors for one week
- participation in another study with exposure to radiation within the last year
- long segment of Barrett*s epithelium

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study outcome:<br /><br>- The position of the postprandial gastric acid pocket relative to the<br /><br>esophagogastric junction</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study outcomes:<br /><br>- Esophageal sensitivity for distension and chemical stimuli (VAS scores)<br /><br>- Concentration of Bile acids in the gastric acid pocket<br /><br>- The rate of postprandial acid reflux events<br /><br>- The size of the postprandial acid pocket<br /><br>- The acidity of postprandial reflux events<br /><br>- The acidity of the postprandial gastric acid pocket<br /><br>- Histology of the esophageal mucosa<br /><br>- Permeability of the esophageal mucosa</p><br>