Antibiotic Resistant Helicobacter Pylori in Rajavithi Hospital

Antibiotic Resistance Helicobacter Pylori and Clarithromycin Resistance Mutation in Helicobacter Pylori in Rajavithi Hospital

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.

Study Overview

• Status: Completed
• Conditions: Dyspepsia
• Intervention / Treatment: Procedure: gastroscopic examination

Detailed Description

Genetic and Biomolecular factors determining clarithromycin resistance will be characterized.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Ratchathewi, Bangkok, Thailand, 10400
      • Rajavithi hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Dydpepsia patient with gastroscopic examination

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of H. pylori Clarithromycin resistance gene	one year

Secondary Outcome Measures

Outcome Measure	Time Frame
Characteristic of H. pylori clarithromycin resistant gene mutation	one year

Collaborators and Investigators

• Sponsor: Rajavithi Hospital
• Investigators: Principal Investigator: Piyathida Harnsoomboon, MD, Rajavithi hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2006
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: February 1, 2006
• First Submitted That Met QC Criteria: February 1, 2006
• First Posted (Estimate): February 2, 2006

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 14, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: H. Pylori, Clarithromycin resistant, gene
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia
• Other Study ID Numbers: RH-CMR-002