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Immediate Detection of Helicobacter Infection With a New Electrochemical System.

This study is currently recruiting participants.
Verified January 2013 by University of Erlangen-Nürnberg Medical School
Sponsor:
Information provided by (Responsible Party):
Helmut Neumann, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT01234389
First received: November 2, 2010
Last updated: January 23, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
H. Pylori Infection
 Device: Electrochemical H. pylori detection method
Device: IHC
Device: C13-urea breath test
Device: HUT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Immediate Detection of Helicobacter Infection With a New Electrochemical System

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Erlangen-Nürnberg Medical School:

Primary Outcome Measures:
  • Effectiveness of the newly developed device in comparison to IHC, HUT and C13-urea breath test. [ Time Frame: Oktober 2009 - February 2011 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: October 2009
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
H. pylori positive patients Device: Electrochemical H. pylori detection method
Determination of H. pylori infection.
Device: IHC
Determination of H. pylori infection.
Other Name: Determination of H. pylori infection.
Device: C13-urea breath test
Determination of H. pylori infection.
Device: HUT
Determination of H. pylori infection.
H. pylori negative patients Device: Electrochemical H. pylori detection method
Determination of H. pylori infection.
Device: IHC
Determination of H. pylori infection.
Other Name: Determination of H. pylori infection.
Device: C13-urea breath test
Determination of H. pylori infection.
Device: HUT
Determination of H. pylori infection.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01234389

Contacts
Contact: Markus F. Neurath, M.D., Ph.D. 4991318535204 markus.neurath@uk-erlangen.de
Contact: Helmut Neumann, M.D., Ph.D. 4991318535204 helmut.neumann@uk-erlangen.de

Locations
Germany
University of Erlangen-Nuremberg Recruiting
Erlangen, Bayern, Germany, 91054
Contact: Markus F. Neurath, M.D., Ph.D.     4991318535204     markus.neurath@uk-erlangen.de    
Contact: Helmut Neumann, M.D., Ph.D.     4991318535204     helmut.neumann@uk-erlangen.de    
Principal Investigator: Helmut Neumann, M.D., Ph.D.            
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
Study Director: Markus F. Neurath, M.D., Ph.D. University of Erlangen-Nuremberg
Principal Investigator: Helmut Neumann, M.D., Ph.D. University of Erlangen-Nuremberg
  More Information

No publications provided

Responsible Party: Helmut Neumann, Professor, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT01234389     History of Changes
Other Study ID Numbers: HN-0004
Study First Received: November 2, 2010
Last Updated: January 23, 2013
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on June 17, 2013