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
INN or Proposed INN: 13C-urea
Concentration unit: IU/mg international unit(s)/milligram
Concentrat
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 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 (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. Culture will be based on antrum biopsies. 4 endoscopic biopsies from the antrum and 1 biopsy from the corpus, and 1 biopsy from the angular fold will be sampled. Histological processing and evaluation will be performed for at least one sample of the antrum and the corpus. Rapid urease test will be performed on the sample of angular fold biopsy. · 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 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 receptor antagonists, NSAIDs, antibiotics, antisecretory 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 test the sensitivity of the 13C-UBT (Helicobacter Test INFAI) using the new test meal (Refex) for Hp in patients with dyspepsia taking PPI with one day break of medication.;Secondary Objective: To test the specificity of the 13C-UBT (Helicobacter Test INFAI) using the new test meal (Refex) for Hp in patients with dyspepsia taking PPI with one day break of medication. To validate the results of the Helicobacter Test INFAI using new test meal for Hp in patients taking PPI with - Histology score for Hp in antrum and corpus using the updated Sydney system - Sex - Age - Body Mass Index (BM));Primary end point(s): Patients taking PPI, a positive test remains reliable for the detection of Hp but the number of false negative tests rises dramatically reducing the sensitivity of these tests. Clinicians are frequently confronted with making a diagnosis of Hp infection in patients wo may knowingly or unknowingly be taking PPI. Currently available breath and stool tests are reliable only 12-14 days after discontinuation of PPI. The aim of this study is to assess the sensitivity and specificity of the 13 C UBT Helicobacter Test INFAI administered with new test meal Refex in patients with dyspepsia taking PPI with one day break of medication instead of two weeks prior to the test. | — |
Countries
Germany
Outcome results
None listed