Diagnosis of Helicobacter pylori infection for patients taking proton pump inhibitors (PPI) with one day break of medication instead of two weeks prior to the test
Conditions
Interventions
Trade Name: Helicobacter Test INFAI
Product Code: V04CX
Pharmaceutical Form: Powder for oral solution
Trade Name: Nexium mups 40 mg
Pharmaceutical Form: Tablet
Sponsors
INFAI Institut für biomedizinische Analytik und NMR Imaging 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 and GERD according Rome IV classification • Positive or negative standard 13C-UBT at screening. • Diagnosis of H. pylori infection confirmed or excluded by combination of culture#, histology* and rapid** urease test (PyloriTek®, Serim Research Corp., Elkhart, USA) on samples obtained by 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 histology and urease test are negative. - Patients will undergo upper endoscopy. Six biopsy samples will be obtained during this procedure. #) Culture will be based on antrum and corpus 2 biopsies. *) two biopsies ( corpus and antrum ) for histology **) two biopsies ( corpus and antrum ) for Rapid urease test(RUT) • Written informed consent of the 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 156 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: • Previous H. pylori eradication therapy. • Intake of PPI in 2 weeks, H2 receptor antagonists 1 day and NSAIDs, antibiotics, anti¬secretory drugs, bismuth compounds, or sucralfate in the 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. • Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm the sensitivity and specificity of the 13C-UBT using the new test meal for H. pylori in patients with dyspepsia and GERD taking PPI.;Secondary Objective: To compare the sensitivity and specificity of the 13C-UBT using the new test meal and standard test meal for H. pylori in patients with dyspepsia and GERD taking PPI. To correlate the results of the Helicobacter Test INFAI® using new test meal for H. pylori in patients with dyspepsia and GERD taking PPI with: •Histology score for H. pylori in antrum and corpus using the updated Sydney System, •Sex, •Age, •Body Mass Index (BMI). ;Primary end point(s): Co-primary efficacy variables: •The proportion of H. pylori positive patients with positive new test result using a cut-off value of 2.5‰ •The proportion of H. pylori negative patients with negative new test result using a cut-off value of 2.5‰ ;Timepoint(s) of evaluation of this end point: Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The proportion of H. pylori positive patients with positive standard test result using a cut-off value of 4‰ • The proportion of H. pylori negative patients with negative standard test result using a cut-off value of 4‰ • The delta over baseline (DOB) or ?d-value [‰] will be calculated from the difference of the 13CO2 / total CO2 ratio 30 min after intake of the urea-13C solution and at baseline. • Coefficients of correlation between DOB and the histology score for H. pylori in antrum and corpus using the Updated Sydney System, sex, age and BMI. ;Timepoint(s) of evaluation of this end point: Day 30 | — |
Countries
Germany
Contacts
Public ContactManaging Director
Infai GmbH
Outcome results
None listed