A clinical study to investigate a new test meal for the determination of sensitivity and specificity of a 13 C -Urea H. pylori test

Phase 1

• Conditions: Diagnosis of Helicobacter pylori infection for patients taking proton pump inhibitors (PPI) with one day break ofmedication instead of two weeks prior to the test; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2017-001369-25-DE
• Lead Sponsor: INFAI Institut für biomedizinische Analytik und NMR Imaging GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-01
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 226

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

•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

Study & Design

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