Antibiotic Resistant Helicobacter Pylori in Rajavithi Hospital

NCT ID: NCT00285688

Last Updated: 2020-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-06-30

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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Genetic and Biomolecular factors determining clarithromycin resistance will be characterized.

Conditions

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Dyspepsia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Gastroscope positive for H. pylori and resistant to clarithromycin

gastroscopic examination

Intervention Type PROCEDURE

gastroscopic examination for tissue biopsy and real time PCR for gene study

2

Gastroscope positive for H. pylori and not resistant to clarithromycin

gastroscopic examination

Intervention Type PROCEDURE

gastroscopic examination for tissue biopsy and real time PCR for gene study

Interventions

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gastroscopic examination

gastroscopic examination for tissue biopsy and real time PCR for gene study

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Department of Medical Services Ministry of Public Health of Thailand

OTHER_GOV

Sponsor Role lead

Responsible Party

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Biomolecular Research Center, Rajavithi hospital: Thailand

Principal Investigators

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Piyathida Harnsoomboon, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Medical Services Ministry of Public Health of Thailand

Locations

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Rajavithi Hospital

Ratchathewi, Bangkok, Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type DERIVED
PMID: 22619884 (View on PubMed)

Other Identifiers

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RH-CMR-002

Identifier Type: -

Identifier Source: org_study_id

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