Two-way Crossover Comparison of the Sensitivity and Specificity of the Modified Helicobacter Test INFAI Using New Test Meal vs. Standard 13C-Urea Breath Test in Helicobacter Pylori Positive and Negative Patients with Dyspepsia Taking Proton Pump Inhibitors

Phase 1

• Conditions: Diagnosis of Helicobacter pylori infection for patients taking proton pump inhibitors (PPI) without interuption of medication two weeks prior to test.

• Registration Number: EUCTR2006-000789-35-CZ
• Lead Sponsor: INFAI GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-08-22
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 115

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

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.

Study & Design

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