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

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.

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Lansoprazole (Lanton); Drug: Omeprezole (Losec); Drug: Pantoprazole(Controloc); Drug: Esomeprazole (Nexium)

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 Type: Interventional
• Enrollment (Actual): 123
• Phase: Phase 4

Contacts and Locations

Study Locations

• Israel
  • Petah Tikva, Israel, 49100
    • Rabin Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lansoprazole (Lanton); Patients with H.pylori infection will take one tablet a day of 20 mg Lansoprazole for 14 days orally in the morning	Drug: Lansoprazole (Lanton); Oral administration of Lanzoprazole for 14 days in 25 patients with H.pylori infection; Other Names: Lanton
Active Comparator: Omeprazole (Losec); Patients with H.pylori infection will take one tablet of 30 mg a day of Omeprazole for 14 days orally in the morning	Drug: Omeprezole (Losec); Oral administration of Omeprazole for 14 days in 25 patients with H.pylori infection; Other Names: Losec
Active Comparator: 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	Drug: Pantoprazole(Controloc); Oral administration of Pantoprazole for 14 days in 25 patients with H.pylori infection; Other Names: Controloc
Active Comparator: Esomeprazole(Nexium); Patients with H.pylori infection will take one tablet a day of 20 mg Esomeprazole for 14 days orally on the morning	Drug: Esomeprazole (Nexium); Oral administration of Esomeprazole for 14 days in 25 patients with H.pylori infection; Other Names: Nexium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urea Breath Test Result (DOB > 5 is Positive)After Different Time Periods From When PPI (Proton Pump Inhibitor) Was Stopped.	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.	17 days

Collaborators and Investigators

• Sponsor: Meridian Bioscience, Inc.
• Collaborators: Rabin Medical Center
• Investigators: Principal Investigator: Haim Shirin, MD, Sharon Hospital

Publications and helpful links

General Publications

• Shirin H, Frenkel D, Shevah O, Levine A, Bruck R, Moss SF, Niv Y, Avni Y. Effect of proton pump inhibitors on the continuous real time (13)C-urea breath test. Am J Gastroenterol. 2003 Jan;98(1):46-50. doi: 10.1111/j.1572-0241.2003.07187.x.

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: January 19, 2009
• First Submitted That Met QC Criteria: January 20, 2009
• First Posted (Estimate): January 21, 2009

Study Record Updates

• Last Update Posted (Actual): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 19, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: PPI; HP; UBT
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Dexlansoprazole; Lansoprazole; Esomeprazole; Pantoprazole
• Other Study ID Numbers: HP-BID 608