Skip to content

The failure of Proton Pump Inhibitors in Gastro Esophageal Reflux Disease

The failure of Proton Pump Inhibitors in Gastro Esophageal Reflux Disease - PPI failure

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON35604
Enrollment
24
Registered
2010-05-18
Start date
2010-04-01
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GERD heartburn

Interventions

stop medication for 1 week

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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 4,5 % 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

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

Design outcomes

Primary

MeasureTime frame
Primary study outcome: - The position of the postprandial gastric acid pocket relative to the esophagogastric junction

Secondary

MeasureTime frame
Secondary study outcomes: - Esophageal sensitivity for distension and chemical stimuli (VAS scores) - Concentration of Bile acids in the gastric acid pocket - The rate of postprandial acid reflux events - The size of the postprandial acid pocket - The acidity of postprandial reflux events - The acidity of the postprandial gastric acid pocket - Histology of the esophageal mucosa - Permeability of the esophageal mucosa

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)