The Sensivity and Specificity of the Modified Helicobacter Test INFAI Using New Test Meal with 13C-Urea Breath Test in Helicobacter Pylori Positive and Negative Patients with Dyspepsia Taking Proton Pump Inhibitors - PPI Study

• Conditions: 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

• Registration Number: EUCTR2008-008010-39-DE
• Lead Sponsor: INFAI Institut für biomedizinische Analytik und NMR Imaging GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-24
• Last Update Posted: 11 February 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 86

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

·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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified