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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.

Tracking Information
First Submitted Date  ICMJE January 19, 2009
First Posted Date  ICMJE January 21, 2009
Results First Submitted Date  ICMJE June 19, 2011
Results First Posted Date  ICMJE October 7, 2011
Last Update Posted Date February 16, 2012
Study Start Date  ICMJE November 2008
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 20, 2009)
Delta Over Baseline will be measured using a 13C Urea breath test [ Time Frame: 15 days ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 13-C Urea Breath Test Using BreathID System and PPIs (Proton Pump Inhibitors)
Official Title  ICMJE The Effect of High Dose Citric on PPI (Proton Pump Inhibitors)Induced False Negative H. Pylori UBT Rates
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Helicobacter Pylori Infection
Intervention  ICMJE
  • Drug: Lansoprazole (Lanton)
    Oral administration of Lanzoprazole for 14 days in 25 patients with H.pylori infection
    Other Name: Lanton
  • Drug: Omeprezole (Losec)
    Oral administration of Omeprazole for 14 days in 25 patients with H.pylori infection
    Other Name: Losec
  • Drug: Pantoprazole(Controloc)
    Oral administration of Pantoprazole for 14 days in 25 patients with H.pylori infection
    Other Name: Controloc
  • Drug: Esomeprazole (Nexium)
    Oral administration of Esomeprazole for 14 days in 25 patients with H.pylori infection
    Other Name: Nexium
Study Arms  ICMJE
  • 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
    Intervention: Drug: Lansoprazole (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
    Intervention: Drug: Omeprezole (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
    Intervention: Drug: Pantoprazole(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
    Intervention: Drug: Esomeprazole (Nexium)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 7, 2011)
123
Original Estimated Enrollment  ICMJE
 (submitted: January 20, 2009)
200
Actual Study Completion Date  ICMJE November 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00825630
Other Study ID Numbers  ICMJE HP-BID 608
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Exalenz Bioscience LTD.
Study Sponsor  ICMJE Exalenz Bioscience LTD.
Collaborators  ICMJE Rabin Medical Center
Investigators  ICMJE
Principal Investigator: Haim Shirin, MD Sharon Hospital
PRS Account Exalenz Bioscience LTD.
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP