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

Sponsor:

ClinicalTrials.gov Identifier:

NCT00285688

First Posted: February 2, 2006

Last Update Posted: August 5, 2008

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.

Information provided by:

Rajavithi Hospital

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:

MedlinePlus related topics: Antibiotics Genes and Gene Therapy Health Facilities 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 ]

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
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

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

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

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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hansomburana P, Anantapanpong S, Sirinthornpunya S, Chuengyong K, Rojborwonwittaya J. Prevalence of single nucleotide mutation in clarithromycin resistant gene of Helicobacter pylori: a 32-months prospective study by using hybridization real time polymerase chain reaction. J Med Assoc Thai. 2012 Mar;95 Suppl 3:S28-35.


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 Submitted:	February 1, 2006
First Posted:	February 2, 2006
Last Update Posted:	August 5, 2008
Last Verified:	August 2008

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 Anti-Infective Agents	Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors

To Top