We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Antibiotic Resistant Helicobacter Pylori in Rajavithi Hospital

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00285688
Recruitment Status : Unknown
Verified August 2008 by Rajavithi Hospital.
Recruitment status was:  Recruiting
First Posted : February 2, 2006
Last Update Posted : August 5, 2008
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Dyspepsia Procedure: gastroscopic examination Phase 3

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

Study Design

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Antibiotic Resistance Helicobacter Pylori and Clarithromycin Resistance Mutation in Helicobacter Pylori in Rajavithi Hospital
Study Start Date : June 2006
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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

Outcome Measures

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

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

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

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00285688

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Piyathida Harnsomburana, Biomolecular Research Center, Rajavithi hospital: Thailand
ClinicalTrials.gov Identifier: NCT00285688     History of Changes
Other Study ID Numbers: RH-CMR-002
First Posted: February 2, 2006    Key Record Dates
Last Update Posted: August 5, 2008
Last Verified: August 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