Ignite Creation Date:
2024-05-05 @ 9:09 PM
Last Modification Date:
2024-10-26 @ 10:00 AM
Study NCT ID:
NCT00825630
Status:
COMPLETED
Last Update Posted:
2022-12-20
First Post:
2009-01-19
Brief Title:
13-C Urea Breath Test Using BreathID System and PPIs Proton Pump Inhibitors
Sponsor:
Meridian Bioscience Inc
Organization:
Meridian Bioscience Inc
Study Overview
Official Title:
The Effect of High Dose Citric on PPI Proton Pump InhibitorsInduced False Negative H Pylori UBT Rates
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Approximately 200 patients with suspected Hpylori will be tested with a 13C-Urea Breath Test UBT to ascertain Hpylori positive 100 HPylori 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
Detailed 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None