Antibiotic Resistant Helicobacter Pylori in Rajavithi Hospital

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Rajavithi Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Rajavithi Hospital
ClinicalTrials.gov Identifier:
NCT00285688
First received: February 1, 2006
Last updated: August 2, 2008
Last verified: August 2008
  Purpose

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Characteristic of H. pylori clarithromycin resistant gene mutation [ Time Frame: one year ] [ Designated as safety issue: No ]

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
1
Gastroscope positive for H. pylori and resistant to clarithromycin
Procedure: gastroscopic examination
gastroscopic examination for tissue biopsy and real time PCR for gene study
2
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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Dydpepsia patient with gastroscopic examination

Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00285688

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

No publications provided by Rajavithi Hospital

Additional 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
Study First Received: February 1, 2006
Last Updated: August 2, 2008
Health Authority: Thailand: Ministry of Public Health

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

Additional relevant MeSH terms:
Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms
Anti-Bacterial Agents
Clarithromycin
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 26, 2014