Diagnosis of Helicobacter pylori infection for patients taking proton pump inhibitors (PPI) without interuption of medication two weeks prior to test.
Conditions
Interventions
Trade Name: Helicobacter Test INFAI
Product Name: Helicobacter Test INFAI
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: 13C Urea
Concentration unit: mg/g milligram(s)/gram
Concent
Sponsors
INFAI GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male and female patients of at least 18 years of age - All acid-related disorders requiring long-term PPI treatment including functional dyspepsia according Rome II Classification - Positive or negative standard 13C-UBT at screening - Diagnosis of Hp infection confirmed or excluded by combination of culture#, histology* and rapid** urease test on samples obtained bz endoscopy: - True positive: culture and/or (histology and rapid urease test) are positive - True negative: at least two tests are negative and culture is not positive - True negative: culture not evaluable and both histologz and urease test are negative. #) Culture will be based on antrum biopsies *) 4 endoscopic biopsies from antrum and 1 biopsy from corpus will be sampled. Histological processing and evaluation will beperformed for at least one sample of the antrum and the corpus. **) Rapid urease test will beperformed on the sampke of antrum biopsy. - Written informed consent of patient Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Previous Hp eradication therapy - intake of PPI, H2 receptors anatgonists, NSAIDs, antibiotics, antisecretory drugs, bismuth compounds, or sucralfate in 4 weeks prior to enrolment - Manifest coagulopathy or any other disorder according to which endoscopy and/or biopsies are contraindicated. - Participation in a clinical trial with another not approved drug within 30 days before entering the study and/or previous participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To compare the specificity of the 13C-UBT using the new test meal and the standard test meal for Hp patients with dyspepsia taking PPI To compare the safety and tolerance of the new test meal with standard test meal To correlate the results of the Helicobacter Test INFAI using ne and standard test meal for Hp in patients with dyspepsia taking PPI: - Histoology score for Hp in antrum and corpus using the Uodate Sydney System - Sex - Age - BMI;Primary end point(s): Patients taking PPI, a positive test remains reliable for detection of Hp but the number of false negative tests risesdramatically reducing the sensitivity of these tests. Clinicians are frequently confronted with making a diagnosis of Hp infection in patients who may knowingly be taking PPI. Currently available breath and stool tests are reliable 12-14 days after discontinuation of PPI. The aim of this study is to asses the sensitivity and specificity of the 13C UBT administered with the new test meal compared to standard Helicobacter Test INFAI in patients with dyspepsia taking PPI in a randomised blinded comparison.;Main Objective: To compare the sensitivity of the 13C-UBT test using the new test meal and the standard test meal for Hp in patients with dyspepsia taking PPI | — |
Countries
Czech Republic
Outcome results
None listed