NCT00825630

13-C Urea Breath Test Using BreathID System and PPIs (Proton Pump Inhibitors)

The Effect of High Dose Citric on PPI (Proton Pump Inhibitors)Induced False Negative H. Pylori UBT Rates

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Meridian Bioscience, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Approximately 200 patients with suspected H.pylori will be tested with a 13C-Urea Breath Test (UBT) to ascertain H.pylori positive. 100 H.Pylori positive patients will tested before and after prescribed with one of the four selected Proton Pump Inhibitors (PPIs); 25 patients in each arm. This will provide information on the influence of PPIs on the UBT (Urea Breath Test). The aim of the trial is to observe the effect of different PPIs on the breath test and choose the optimal protocol of when to stop PPI. The hypothesis is that there will be a minimal effect on the UBT while using selected PPIs.

Detailed description

Adult subjects with suspected H pylori infection will be recruited and will undergo a 13C -Urea breath test (including citrica) with the BreathID test device. Those were found positive will undergo selected PPI treatment for 14 days and after 24 or 72 hours from the completion of the two weeks, will undergo a second breath test. Those found to be negative (false negative), will undergo additional breath tests. * Those subjects that underwent any antibiotic, bismuth or PPI therapy 4 weeks prior to the trial, are to be excluded. * Furthermore, pregnant or nursing women and subjects with an allergy or sensitivity to one of the tests substrates, will be excluded from the study.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	Lansoprazole (Lanton)	Oral administration of Lanzoprazole for 14 days in 25 patients with H.pylori infection
DRUG	Omeprezole (Losec)	Oral administration of Omeprazole for 14 days in 25 patients with H.pylori infection
DRUG	Pantoprazole(Controloc)	Oral administration of Pantoprazole for 14 days in 25 patients with H.pylori infection
DRUG	Esomeprazole (Nexium)	Oral administration of Esomeprazole for 14 days in 25 patients with H.pylori infection

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2009-01-21
• Last updated: 2022-12-20
• Results posted: 2011-10-07

Locations

1 site across 1 country: Israel