Official Title: “Antibiotic Resistance Helicobacter Pylori and Clarithromycin Resistance Mutation in Helicobacter Pylori in Rajavithi Hospital”

Peptic ulcer disease is the most common gastrointestinal disease. Antibiotic resistant Helicobacter pylori is a major problem worldwide. The gold standard for Helicobacter pylori eradication is composed of Proton-pump inhibitor/Ranitidine bismuth citrate + Amoxycillin + Metronidazole /Clarithromycin. In Thailand, clarithromycin resistant strains increased and led to treatment failure. Data on file at Rajavithi Hospital showed that metronidazole resistant H. pylori was about 50% and Clarithromycin resistant strains accounted for 8%. This molecular genetic study will be performed in patients presenting with dyspepsia, who had an indication for gastroscopic examination, to explore the incidence of antibiotic resistant Helicobacter pylori in Rajavithi Hospital, Thailand.

Study Type: Observational

Study Design: Case Control, Prospective

Genetic and Biomolecular factors determining clarithromycin resistance will be characterized.

Intervention(s) in this Clinical Trial

• Procedure: gastroscopic examination
  • gastroscopic examination for tissue biopsy and real time PCR for gene study

Arms, Groups and Cohorts in this Clinical Trial

• : 1
  • Gastroscope positive for H. pylori and resistant to clarithromycin
• : 2
  • Gastroscope positive for H. pylori and not resistant to clarithromycin

Primary Measures

• Incidence of H. pylori Clarithromycin resistance gene
  • Time Frame: one year
    Safety Issue?: No

Secondary Measures

• Characteristic of H. pylori clarithromycin resistant gene mutation
  • Time Frame: one year
    Safety Issue?: No

Inclusion Criteria:

• male or female with dyspepsia
• age > 15 years
• fulfil indication for gastroscopic examination
• able to give informed consent

Exclusion Criteria:

• contraindication for gastroscopic examination and biopsy

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 15 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Rajavithi Hospital

Overall Clinical Trial Officials and Contacts

Piyathida Harnsoomboon, MD Principal Investigator Rajavithi Hospital  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00285688

Study ID Number: RH-CMR-002

ClinicalTrials.gov Identifier: NCT00285688

Health Authority: Thailand: Ministry of Public Health