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

Phase 4

Completed

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: Lansoprazole (Lanton); Drug: Omeprezole (Losec); Drug: Esomeprazole (Nexium); Drug: Pantoprazole(Controloc)

• Registration Number: NCT00825630
• Lead Sponsor: Meridian Bioscience, Inc.

Brief 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.

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2009-01-19
• Study First Submitted QC: 2009-01-20
• Study First Posted: 2009-01-21
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Results First Submitted: 2011-06-19
• Results First Submitted QC: 2011-09-07
• Results First Posted: 2011-10-07
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-19
• Last Update Posted: 2022-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lansoprazole (Lanton)	Lansoprazole (Lanton)	Patients with H.pylori infection will take one tablet a day of 20 mg Lansoprazole for 14 days orally in the morning
Omeprazole (Losec)	Omeprezole (Losec)	Patients with H.pylori infection will take one tablet of 30 mg a day of Omeprazole for 14 days orally in the morning
Esomeprazole(Nexium)	Esomeprazole (Nexium)	Patients with H.pylori infection will take one tablet a day of 20 mg Esomeprazole for 14 days orally on the morning
Pantoprazole (Controloc)	Pantoprazole(Controloc)	Patients with H.pylori infection will take one tablet a day of 40 mg of Pantoprazole for 14 days orally in the morning

Primary Outcome Measures

Name	Time	Method
Urea Breath Test Result (DOB > 5 is Positive)After Different Time Periods From When PPI (Proton Pump Inhibitor) Was Stopped.	17 days	Negative value is defined as delta over baseline (DOB) less than 5. The subjects who were positive (DOB\>=5) for H.Pylori and after PPI for 10 days repeated a breath with a negative (DOB\<5) were considered false negatives. The breath test has been cleared by the FDA in a 510(k) and has \> 96% accuracy.

Trial Locations

Locations (1)

Rabin Medical Center; 🇮🇱 Petah Tikva, Israel