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Antibiotic Resistant Helicobacter Pylori in Rajavithi Hospital

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ClinicalTrials.gov Identifier: NCT00285688
Recruitment Status : Completed
First Posted : February 2, 2006
Last Update Posted : October 19, 2020
Sponsor:
Information provided by:
Rajavithi Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Dyspepsia Procedure: gastroscopic examination

Detailed Description:
Genetic and Biomolecular factors determining clarithromycin resistance will be characterized.
Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Antibiotic Resistance Helicobacter Pylori and Clarithromycin Resistance Mutation in Helicobacter Pylori in Rajavithi Hospital
Actual Study Start Date : June 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

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Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of H. pylori Clarithromycin resistance gene [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Characteristic of H. pylori clarithromycin resistant gene mutation [ Time Frame: one year ]

Biospecimen Retention:   Samples With DNA
Gastric Biopsy tissue and H. pylori DNA

Eligibility Criteria
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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
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
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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
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Thailand
Rajavithi Hospital
Ratchathewi, Bangkok, Thailand, 10400
Sponsors and Collaborators
Rajavithi Hospital
Investigators
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Principal Investigator: Piyathida Harnsoomboon, MD Rajavithi Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr Piyathida Harnsomburana, Biomolecular Research Center, Rajavithi hospital: Thailand
ClinicalTrials.gov Identifier: NCT00285688    
Other Study ID Numbers: RH-CMR-002
First Posted: February 2, 2006    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Keywords provided by Rajavithi Hospital:
H. Pylori, Clarithromycin resistant, gene
Additional relevant MeSH terms:
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Dyspepsia
Signs and Symptoms, Digestive