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

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ClinicalTrials.gov Identifier: NCT00825630
Recruitment Status : Completed
First Posted : January 21, 2009
Results First Posted : October 7, 2011
Last Update Posted : February 16, 2012
Sponsor:
Collaborator:
Rabin Medical Center
Information provided by (Responsible Party):
Exalenz Bioscience LTD.

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.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: Lansoprazole (Lanton) Drug: Omeprezole (Losec) Drug: Pantoprazole(Controloc) Drug: Esomeprazole (Nexium) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Effect of High Dose Citric on PPI (Proton Pump Inhibitors)Induced False Negative H. Pylori UBT Rates
Study Start Date : November 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: 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 Name: Nexium




Primary Outcome Measures :
  1. Urea Breath Test Result (DOB > 5 is Positive)After Different Time Periods From When PPI (Proton Pump Inhibitor) Was Stopped. [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00825630


Locations
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Israel
Rabin Medical Center
Petah Tikva, Israel, 49100
Sponsors and Collaborators
Exalenz Bioscience LTD.
Rabin Medical Center
Investigators
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Principal Investigator: Haim Shirin, MD Sharon Hospital
Publications of Results:
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Responsible Party: Exalenz Bioscience LTD.
ClinicalTrials.gov Identifier: NCT00825630    
Other Study ID Numbers: HP-BID 608
First Posted: January 21, 2009    Key Record Dates
Results First Posted: October 7, 2011
Last Update Posted: February 16, 2012
Last Verified: February 2012
Keywords provided by Exalenz Bioscience LTD.:
HP
UBT
PPI
Additional relevant MeSH terms:
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Esomeprazole
Pantoprazole
Lansoprazole
Dexlansoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action