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NCT00285688 Clinical Trial

Antibiotic Resistant Helicobacter Pylori in Rajavithi Hospital

Dyspepsia Clinical Trial

Official title:
Antibiotic Resistance Helicobacter Pylori and Clarithromycin Resistance Mutation in Helicobacter Pylori in Rajavithi Hospital

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00285688
Other study ID # RH-CMR-002
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2006
Est. completion date December 2007

Study information
Verified date October 2020
Source Rajavithi Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

Genetic and Biomolecular factors determining clarithromycin resistance will be characterized.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender All
Age group 15 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• gastroscopic examination
gastroscopic examination for tissue biopsy and real time PCR for gene study

Locations
Country Name City State
Thailand Rajavithi Hospital Ratchathewi Bangkok

Sponsors (1)
Lead Sponsor Collaborator
Rajavithi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of H. pylori Clarithromycin resistance gene one year
Secondary Characteristic of H. pylori clarithromycin resistant gene mutation one year
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