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Antibiotic Resistant Helicobacter Pylori in Rajavithi Hospital

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2008 by Rajavithi Hospital.
Recruitment status was:  Recruiting
Information provided by:
Rajavithi Hospital Identifier:
First received: February 1, 2006
Last updated: August 2, 2008
Last verified: August 2008
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.

Condition Intervention Phase
Dyspepsia Procedure: gastroscopic examination Phase 3

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Antibiotic Resistance Helicobacter Pylori and Clarithromycin Resistance Mutation in Helicobacter Pylori in Rajavithi Hospital

Resource links provided by NLM:

Further study details as provided by Rajavithi Hospital:

Primary Outcome Measures:
  • Incidence of H. pylori Clarithromycin resistance gene [ Time Frame: one year ]

Secondary Outcome Measures:
  • Characteristic of H. pylori clarithromycin resistant gene mutation [ Time Frame: one year ]

Biospecimen Retention:   Samples With DNA
Gastric Biopsy tissue and H. pylori DNA

Estimated Enrollment: 200
Study Start Date: June 2006
Estimated Study Completion Date: December 2008
Groups/Cohorts Assigned Interventions
Gastroscope positive for H. pylori and resistant to clarithromycin
Procedure: gastroscopic examination
gastroscopic examination for tissue biopsy and real time PCR for gene study
Gastroscope positive for H. pylori and not resistant to clarithromycin
Procedure: gastroscopic examination
gastroscopic examination for tissue biopsy and real time PCR for gene study

Detailed Description:
Genetic and Biomolecular factors determining clarithromycin resistance will be characterized.

Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Dydpepsia patient with gastroscopic examination

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00285688

Rajavithi Hospital Recruiting
Ratchathewi, Bangkok, Thailand, 10400
Contact: Piyathida Harnsomboonrana, M.D.    6618423854   
Sponsors and Collaborators
Rajavithi Hospital
Principal Investigator: Piyathida Harnsoomboon, MD Rajavithi Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr Piyathida Harnsomburana, Biomolecular Research Center, Rajavithi hospital: Thailand Identifier: NCT00285688     History of Changes
Other Study ID Numbers: RH-CMR-002
Study First Received: February 1, 2006
Last Updated: August 2, 2008

Keywords provided by Rajavithi Hospital:
H. Pylori, Clarithromycin resistant, gene

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors processed this record on September 21, 2017