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

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00825630
• Other study ID #: HP-BID 608
• Status: Completed
• Phase: Phase 4
• Start date: November 2008
• Est. completion date: November 2009

Study information

• Verified date: December 2022
• Source: Meridian Bioscience, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Helicobacter Pylori Infection

Intervention

Drug:
• Lansoprazole (Lanton)
Oral administration of Lanzoprazole for 14 days in 25 patients with H.pylori infection
• Omeprezole (Losec)
Oral administration of Omeprazole for 14 days in 25 patients with H.pylori infection
• Pantoprazole(Controloc)
Oral administration of Pantoprazole for 14 days in 25 patients with H.pylori infection
• Esomeprazole (Nexium)
Oral administration of Esomeprazole for 14 days in 25 patients with H.pylori infection

Locations

Country	Name	City	State
Israel	Rabin Medical Center	Petah Tikva

Sponsors (2)

Lead Sponsor	Collaborator
Meridian Bioscience, Inc.	Rabin Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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