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

Meridian Bioscience

Status and phase: Completed; Phase 4

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Omeprezole (Losec); Drug: Lansoprazole (Lanton); Drug: Pantoprazole(Controloc); Drug: Esomeprazole (Nexium)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00825630

HP-BID 608

Details and patient eligibility

About

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.

Full 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.

Enrollment: 123 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults with H.pylori infection.

Exclusion criteria

• Pregnancy,
• Nursing,
• Antibiotic, bismuth or PPI treatment 2 weeks prior to trial,
• Known sensitivity to Urea or citrica.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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123 participants in 4 patient groups

Lansoprazole (Lanton)

Active Comparator group

Description:

Patients with H.pylori infection will take one tablet a day of 20 mg Lansoprazole for 14 days orally in the morning

Treatment:

Drug: Lansoprazole (Lanton)

Omeprazole (Losec)

Active Comparator group

Description:

Patients with H.pylori infection will take one tablet of 30 mg a day of Omeprazole for 14 days orally in the morning

Treatment:

Drug: Omeprezole (Losec)

Pantoprazole (Controloc)

Active Comparator group

Description:

Patients with H.pylori infection will take one tablet a day of 40 mg of Pantoprazole for 14 days orally in the morning

Treatment:

Drug: Pantoprazole(Controloc)

Esomeprazole(Nexium)

Active Comparator group

Description:

Patients with H.pylori infection will take one tablet a day of 20 mg Esomeprazole for 14 days orally on the morning

Treatment:

Drug: Esomeprazole (Nexium)