Tailored H. Pylori Eradication Based on Clarithromycin Resistance

The investigators investigated the point mutations in the 23S rRNA genes of patients infected with clarithromycin-resistant H. pylori and compared the H. pylori eradication rates based on the identified clinically significant point mutations.

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Key information

Conditions

Helicobacter Pylori Infection Antibiotic Resistant Strain

Age range

19 year–85 year

Sex eligibility

All sexes

Study type

Observational

About this study

Sequencing-based detection of point mutations identified four mutations that were considered clinically significant (A2142G, A2142C, A2143G, A2143C), while all the other mutations were considered clinically insignificant.

Participants who did not have point mutations related to clarithromycin resistance and/or had clinically insignificant point mutations were treated with PAC (proton pump inhibitor, amoxicillin, clarithromycin) for 7 days, while participants with clinically significant point mutations were treated with PAM (proton pump inhibitor, amoxicillin, metronidazole) for 7 days. H. pylori eradication rates were compared between the two groups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Clinical diagnosis of Helicobacter pylori infection

Exclusion criteria

H. pylori eradication therapy within 1 year,
antibiotics within 4 weeks,
surgery for gastric cancer
malignant tumors other than gastric cancer
end-stage renal disease
liver cirrhosis,
pregnancy

Treatment and study plan

proton pump inhibitor, amoxicillin, clarithromycin

Drug

non-resistant group with treatment of proton pump inhibitor, amoxicillin, clarithromycin

proton pump inhibitor, amoxicillin, metronidazole

Drug

clarithromycin-resistant group with treatment of proton pump inhibitor, amoxicillin, metronidazole

Primary outcomes

Helicobacter pylori eradication rate

Time frame: 2 year

Number of participant with successful Helicobacter pylori eradication

Sponsors and collaborators

Lead sponsor

Kangdong Sacred Heart Hospital

Other

Registry information

Official study title

Helicobacter Pylori Eradication According to Sequencing-based 23S Ribosomal RNA Point Mutation Associated With Clarithromycin Resistance

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Mar 21, 2019
Registry last updated: Mar 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed