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

NCT00825630 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2022-12-20

Study results available
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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.

Conditions

  • Helicobacter Pylori Infection

Interventions

DRUG

Lansoprazole (Lanton)

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

DRUG

Omeprezole (Losec)

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

DRUG

Pantoprazole(Controloc)

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

DRUG

Esomeprazole (Nexium)

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

Sponsors & Collaborators

  • Rabin Medical Center

    collaborator OTHER

  • Meridian Bioscience, Inc.

    lead INDUSTRY

Principal Investigators

  • Haim Shirin, MD · Sharon Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00825630 on ClinicalTrials.gov