Dyspepsia | Antibiotic Resistant Helicobacter Pylori in Rajavithi Hospital
Dyspepsia research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Procedure:gastroscopic examinationgastroscopic examination for tissue biopsy and real time PCR for gene study
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
1Gastroscope positive for H. pylori and resistant to clarithromycin
2Gastroscope positive for H. pylori and not resistant to clarithromycin
Start Date: June 2006
Completed Date: December 2008
Phase: Phase 3
Primary Outcome: Incidence of H. pylori Clarithromycin resistance gene
Secondary Outcome: Characteristic of H. pylori clarithromycin resistant gene mutation
Study sponsors, principal investigator, and references
Principal Investigator: Piyathida Harnsoomboon, MD
Lead Sponsor: Rajavithi Hospital