Title

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
  • Phase

    Phase 4
  • Study Type

    Interventional
  • Study Participants

    123
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.
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 Started
Nov 30
2008
Primary Completion
Nov 30
2009
Study Completion
Nov 30
2009
Results Posted
Oct 07
2011
Estimate
Last Update
Feb 16
2012
Estimate

Drug Lansoprazole (Lanton)

Oral administration of Lanzoprazole for 14 days in 25 patients with H.pylori infection

  • Other names: Lanton

Drug Omeprezole (Losec)

Oral administration of Omeprazole for 14 days in 25 patients with H.pylori infection

  • Other names: Losec

Drug Pantoprazole(Controloc)

Oral administration of Pantoprazole for 14 days in 25 patients with H.pylori infection

  • Other names: Controloc

Drug Esomeprazole (Nexium)

Oral administration of Esomeprazole for 14 days in 25 patients with H.pylori infection

  • Other names: Nexium

Lansoprazole (Lanton) Active Comparator

Patients with H.pylori infection will take one tablet a day of 20 mg Lansoprazole for 14 days orally in the morning

Omeprazole (Losec) Active Comparator

Patients with H.pylori infection will take one tablet of 30 mg a day of Omeprazole for 14 days orally in the morning

Pantoprazole (Controloc) Active Comparator

Patients with H.pylori infection will take one tablet a day of 40 mg of Pantoprazole for 14 days orally in the morning

Esomeprazole(Nexium) Active Comparator

Patients with H.pylori infection will take one tablet a day of 20 mg Esomeprazole for 14 days orally on the morning

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.

Summary

Esomeprazole (Nexium)

Lansoprazole (Lanton)

Omeprazole( Losec)

Pantoprazole (Controloc)

All Events

Event Type Organ System Event Term

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.

Lansoprazole (Lanton)

False negatives (DOB<5) after 1 day of no PPI

2.0
participants

False negatives (DOB<5) after 3 days of no PPI

1.0
participants

Omeprazole( Losec)

False negatives (DOB<5) after 1 day of no PPI

4.0
participants

False negatives (DOB<5) after 3 days of no PPI

3.0
participants

Pantoprazole (Controloc)

False negatives (DOB<5) after 1 day of no PPI

2.0
participants

False negatives (DOB<5) after 3 days of no PPI

1.0
participants

Esomeprazole (Nexium)

False negatives (DOB<5) after 1 day of no PPI

1.0
participants

False negatives (DOB<5) after 3 days of no PPI

Total

123
Participants

Age Continuous

52.46
years (Mean)
Standard Deviation: 14.01

H. Pyori Positive

123
particpants

Age, Categorical

Region of Enrollment

Sex: Female, Male

Overall Study

Lansoprazole (Lanton)

Omeprazole( Losec)

Pantoprazole (Controloc)

Esomeprazole (Nexium)