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NCT Number: NCT00825630

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

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.

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Key information

Conditions

Helicobacter Pylori Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rabin Medical Center

Petah Tikva, 49100, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lansoprazole (Lanton)

Drug

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

Other names: Lanton

Omeprezole (Losec)

Drug

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

Other names: Losec

Pantoprazole(Controloc)

Drug

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

Other names: Controloc

Esomeprazole (Nexium)

Drug

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

Other names: Nexium

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Meridian Bioscience, Inc.

Industry

Collaborators

  • Rabin Medical Center

Registry information

Official study title

The Effect of High Dose Citric on PPI (Proton Pump Inhibitors)Induced False Negative H. Pylori UBT Rates

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 21, 2009
Registry last updated
Dec 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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