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Antibiotic Resistant Helicobacter Pylori in Rajavithi Hospital

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ClinicalTrials.gov Identifier: NCT00285688
Recruitment Status : Unknown
Verified August 2008 by Rajavithi Hospital.
Recruitment status was:  Recruiting
First Posted : February 2, 2006
Last Update Posted : August 5, 2008
Sponsor:
Information provided by:
Rajavithi Hospital

Tracking Information
First Submitted Date February 1, 2006
First Posted Date February 2, 2006
Last Update Posted Date August 5, 2008
Study Start Date June 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: January 7, 2008)
Incidence of H. pylori Clarithromycin resistance gene [ Time Frame: one year ]
Original Primary Outcome Measures
 (submitted: February 1, 2006)
Incidence of H. pyroli resistance strain
Change History Complete list of historical versions of study NCT00285688 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 7, 2008)
Characteristic of H. pylori clarithromycin resistant gene mutation [ Time Frame: one year ]
Original Secondary Outcome Measures
 (submitted: February 1, 2006)
Characteristic of H. pyroli genetic mutation
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Antibiotic Resistant Helicobacter Pylori in Rajavithi Hospital
Official Title Antibiotic Resistance Helicobacter Pylori and Clarithromycin Resistance Mutation in Helicobacter Pylori in Rajavithi Hospital
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.
Detailed Description Genetic and Biomolecular factors determining clarithromycin resistance will be characterized.
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Gastric Biopsy tissue and H. pylori DNA
Sampling Method Non-Probability Sample
Study Population Dydpepsia patient with gastroscopic examination
Condition Dyspepsia
Intervention Procedure: gastroscopic examination
gastroscopic examination for tissue biopsy and real time PCR for gene study
Study Groups/Cohorts
  • 1
    Gastroscope positive for H. pylori and resistant to clarithromycin
    Intervention: Procedure: gastroscopic examination
  • 2
    Gastroscope positive for H. pylori and not resistant to clarithromycin
    Intervention: Procedure: gastroscopic examination
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: February 1, 2006)
200
Original Enrollment Same as current
Estimated Study Completion Date December 2008
Primary Completion Date Not Provided
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Thailand
Removed Location Countries  
 
Administrative Information
NCT Number NCT00285688
Other Study ID Numbers RH-CMR-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr Piyathida Harnsomburana, Biomolecular Research Center, Rajavithi hospital: Thailand
Study Sponsor Rajavithi Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Piyathida Harnsoomboon, MD Rajavithi Hospital
PRS Account Rajavithi Hospital
Verification Date August 2008