Antibiotic Resistant Helicobacter Pylori in Rajavithi Hospital - Full Text View

Sponsor:	Rajavithi Hospital
Information provided by:	Rajavithi Hospital
ClinicalTrials.gov Identifier:	NCT00285688

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 III

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

Resource links provided by NLM:

Genetics Home Reference related topics: Help Me Understand Genetics

MedlinePlus related topics: Antibiotics Indigestion

Drug Information available for: Clarithromycin

U.S. FDA Resources

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

Biospecimen Description:

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

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

Locations

Thailand, Bangkok
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

Responsible Party:	Biomolecular Research Center, Rajavithi hospital: Thailand ( Dr Piyathida Harnsomburana )
Study ID Numbers:	RH-CMR-002
Study First Received:	February 1, 2006
Last Updated:	August 2, 2008
ClinicalTrials.gov Identifier:	NCT00285688 History of Changes
Health Authority:	Thailand: Ministry of Public Health

Keywords provided by Rajavithi Hospital:

H. Pylori, Clarithromycin resistant, gene

Additional relevant MeSH terms:

Protein Synthesis Inhibitors
Anti-Infective Agents
Clarithromycin
Anti-Bacterial Agents
Signs and Symptoms
Molecular Mechanisms of Pharmacological Action

Signs and Symptoms, Digestive
Therapeutic Uses
Enzyme Inhibitors
Dyspepsia
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010