Immediate Detection of Helicobacter Infection With a New Electrochemical System.

University of Erlangen-Nürnberg Medical School

Status: Completed

Conditions: H. Pylori Infection

Treatments: Device: C13-urea breath test; Device: Electrochemical H. pylori detection method; Device: HUT; Device: IHC

Study type: Interventional

Funder types: Other

Identifiers

NCT01234389

HN-0004

Details and patient eligibility

About

Helicobacter pylori-infection (H. pylori) affects about fifty percent of the general population and is associated with peptic ulcer disease, non-cardia gastric adenocarcinoma and gastric lymphoma. Currently, diagnostic methods include breath tests, serology, stool antigen tests, histology or the Helicobacter urease test (HUT).

The aim of our study is to access the clinical reliability of a new, electrochemical device for rapid H. pylori detection.

Full description

The newly developed electrochemical device for H. pylori detection consists of a working and reference electrode between which a biopsy sample is administered. Afterwards, acquired voltage-values could be analysed for characteristics typical for H. pylori infection (ammonia). According to Sydney classification, biopsies are taken from gastric antrum and corpus for electrochemical H. pylori detection, HUT and immunohistochemistry (IHC). HUT results are evaluated after 24 hours. Furthermore, every patient will receive 13C-urea breath test. IHC is designated as the gold standard of H. pylori diagnosis.

Enrollment: 120 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Written informed consent
• Age 18-85 years
• Ability of subjects to understand character and individual consequences of clinical trial
• Subjects undergoing EGD

Exclusion criteria

• Inability to provide written informed consent
• Severe Coagulopathy (Prothrombin time < 50% of control, Partial thromboplastin time > 50 s)
• Pregnancy or breast feeding
• Active gastrointestinal bleeding
• Residing in institutions (e.g. prison)
• PPI intake
• antibiotic use, actual or within the last 4 weeks

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

H. pylori positive patients

Other group

Treatment:

Device: Electrochemical H. pylori detection method

Device: HUT

Device: C13-urea breath test

Device: IHC

H. pylori negative patients

Other group

Treatment:

Device: Electrochemical H. pylori detection method

Device: HUT

Device: C13-urea breath test

Device: IHC