Antibiotic Resistant Helicobacter Pylori in Rajavithi Hospital

NCT00285688 | Completed DMC

• 1 other identifier: RH-CMR-002
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyspepsia

Keywords

H. Pylori, Clarithromycin resistant, gene

Outcome Measures

Primary Outcomes (1)

• Incidence of H. pylori Clarithromycin resistance gene

  one year

Secondary Outcomes (1)

• Characteristic of H. pylori clarithromycin resistant gene mutation

  one year

Study Arms (2)

1

Gastroscope positive for H. pylori and resistant to clarithromycin

Procedure: gastroscopic examination

2

Gastroscope positive for H. pylori and not resistant to clarithromycin

Procedure: gastroscopic examination

Interventions

gastroscopic examination PROCEDURE

gastroscopic examination for tissue biopsy and real time PCR for gene study

1; 2

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Dydpepsia patient with gastroscopic examination

You may qualify if:

• male or female with dyspepsia
• age \> 15 years
• fulfil indication for gastroscopic examination
• able to give informed consent

You may not qualify if:

• contraindication for gastroscopic examination and biopsy

Sponsors & Collaborators

• Department of Medical Services Ministry of Public Health of Thailand: lead

Study Sites (1)

Rajavithi Hospital

Ratchathewi, Bangkok, 10400, Thailand

Location

Related Publications (1)

• 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.

  PMID: 22619884 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Gastric Biopsy tissue and H. pylori DNA

MeSH Terms

Conditions

Dyspepsia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Piyathida Harnsoomboon, MD

  Department of Medical Services Ministry of Public Health of Thailand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: February 1, 2006
• First Posted: February 2, 2006
• Study Start: June 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: October 19, 2020

Record last verified: 2020-10

Locations

TH (1)