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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
Recruitment status was: Recruiting
Sponsor:
Rajavithi Hospital
Information provided by:
Rajavithi Hospital
ClinicalTrials.gov Identifier:
NCT00285688
First received: February 1, 2006
Last updated: August 2, 2008
Last verified: August 2008
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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:
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| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00285688
Please refer to this study by its ClinicalTrials.gov identifier: 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):
| 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 |
| Study First Received: | February 1, 2006 |
| Last Updated: | August 2, 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 |
ClinicalTrials.gov processed this record on August 17, 2017