NCT00825630|CompletedPhase 4ResultsDMC
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
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Sponsor study identifier
interventional
123
1 country
1
Study Start
November 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2009
Actual (reported)Study Completion
November 2009
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2009
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2008
Date type not reportedThis date has not been verified as actual or estimated.
January 19, 2009
Actual (reported)January 21, 2009
Actual (reported)November 2009
Actual (reported)November 2009
Actual (reported)October 7, 2011
Actual (reported)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
Patients with H.pylori infection will take one tablet a day of 20 mg Lansoprazole for 14 days orally in the morning
Patients with H.pylori infection will take one tablet of 30 mg a day of Omeprazole for 14 days orally in the morning
Patients with H.pylori infection will take one tablet a day of 40 mg of Pantoprazole for 14 days orally in the morning
Oral administration of Lanzoprazole for 14 days in 25 patients with H.pylori infection
Oral administration of Omeprazole for 14 days in 25 patients with H.pylori infection
Rabin Medical Center
Petah Tikva, 49100, Israel
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.
It was hard to get people to agree to return for multiple tests within a few days, so the enrollment was difficult
Haim Shirin, MD
Sharon Hospital
123 participants (actual enrollment reported by the registry).
First Submitted
January 19, 2009
First Posted
January 21, 2009
Study Start
November 2008
Date type not reportedThis date has not been verified as actual or estimated.
Patients with H.pylori infection will take one tablet a day of 20 mg Esomeprazole for 14 days orally on the morning
Oral administration of Pantoprazole for 14 days in 25 patients with H.pylori infection
Oral administration of Esomeprazole for 14 days in 25 patients with H.pylori infection
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Primary Completion
November 2009
Actual (reported)Study Completion
November 2009
Actual (reported)Last Updated
December 20, 2022
Results First Posted
October 7, 2011
Record last verified: 2022-12
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Source: ClinicalTrials.gov.
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