Tailored H. Pylori Eradication Based on Clarithromycin Resistance
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ClinicalTrials.gov Identifier: NCT03884348 |
Recruitment Status :
Completed
First Posted : March 21, 2019
Last Update Posted : March 21, 2019
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Condition or disease | Intervention/treatment |
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Helicobacter Pylori Infection Antibiotic Resistant Strain | Drug: proton pump inhibitor, amoxicillin, clarithromycin Drug: proton pump inhibitor, amoxicillin, metronidazole |
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.
Study Type : | Observational |
Actual Enrollment : | 431 participants |
Observational Model: | Case-Only |
Time Perspective: | Retrospective |
Official Title: | Helicobacter Pylori Eradication According to Sequencing-based 23S Ribosomal RNA Point Mutation Associated With Clarithromycin Resistance |
Actual Study Start Date : | January 1, 2017 |
Actual Primary Completion Date : | December 31, 2018 |
Actual Study Completion Date : | December 31, 2018 |

Group/Cohort | Intervention/treatment |
---|---|
PAM-treated clarithromycin-resistance group
Treatment with PPI twice a day, amoxicillin (1000 mg) twice a day, and metronidazole (500 mg) three times a day for 7 days in patients with clinically significant point mutations
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Drug: proton pump inhibitor, amoxicillin, metronidazole
clarithromycin-resistant group with treatment of proton pump inhibitor, amoxicillin, metronidazole |
PAC-treated nonresistance group
Treatment with PPI twice a day, amoxicillin (1000 mg) twice a day, and clarithromycin (500 mg) twice a day for 7 day in patients with clinically insignificant point mutations
|
Drug: proton pump inhibitor, amoxicillin, clarithromycin
non-resistant group with treatment of proton pump inhibitor, amoxicillin, clarithromycin |
- Helicobacter pylori eradication rate [ Time Frame: 2 year ]Number of participant with successful Helicobacter pylori eradication

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Ages Eligible for Study: | 19 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884348
Principal Investigator: | Woon Geon Shin | Kangdong Sacred Heart Hospital |
Responsible Party: | Shin, Woon Geon, Principal Investigator, Kangdong Sacred Heart Hospital |
ClinicalTrials.gov Identifier: | NCT03884348 |
Other Study ID Numbers: |
Kangdong2017-03-005 |
First Posted: | March 21, 2019 Key Record Dates |
Last Update Posted: | March 21, 2019 |
Last Verified: | March 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Sprains and Strains Wounds and Injuries Amoxicillin Metronidazole Clarithromycin Proton Pump Inhibitors Anti-Bacterial Agents Anti-Infective Agents |
Antiprotozoal Agents Antiparasitic Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |