Antibiotic Resistant Helicobacter Pylori in Rajavithi Hospital
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- Incidence of H. pylori Clarithromycin resistance gene [ Time Frame: one year ] [ Designated as safety issue: No ]
- Characteristic of H. pylori clarithromycin resistant gene mutation [ Time Frame: one year ] [ Designated as safety issue: No ]
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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Dydpepsia patient with gastroscopic examination
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| Thailand | |
| Rajavithi Hospital | Recruiting |
| Ratchathewi, Bangkok, Thailand, 10400 | |
| Contact: Piyathida Harnsomboonrana, M.D. 6618423854 pboontee@yahoo.com | |
| Principal Investigator: | Piyathida Harnsoomboon, MD | Rajavithi Hospital |
More Information
No publications provided by Rajavithi Hospital
Additional 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 |
| Health Authority: | Thailand: Ministry of Public Health |
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 |
Therapeutic Uses Pharmacologic Actions Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013