Phase 4
N=123
13-C Urea Breath Test Using BreathID System and PPIs (Proton Pump Inhibitors)
Helicobacter Pylori Infection
Bottom Line
View on ClinicalTrials.gov: NCT00825630 ↗Enrolled (actual)
123
Serious AEs
0.0%
Results posted
Oct 2011
Primary outcome: Primary: Urea Breath Test Result (DOB > 5 is Positive)After Different Time Periods From When PPI (Proton Pump Inhibitor) Was Stopped. — 1; 3; 1; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lansoprazole (Lanton) (Drug); Omeprezole (Losec) (Drug); Pantoprazole(Controloc) (Drug); Esomeprazole (Nexium) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Meridian Bioscience, Inc.
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Urea Breath Test Result (DOB > 5 is Positive)After Different Time Periods From When PPI (Proton Pump Inhibitor) Was Stopped. |
1; 3; 1; 0; 2; 4 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00825630). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.