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

Sponsor:

Information provided by (Responsible Party):

Shin, Woon Geon, Kangdong Sacred Heart Hospital

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment
Helicobacter Pylori Infection Antibiotic Resistant Strain	Drug: proton pump inhibitor, amoxicillin, clarithromycin Drug: proton pump inhibitor, amoxicillin, metronidazole

Detailed Description:

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 Design

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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

Resource links provided by the National Library of Medicine

Drug Information available for: Metronidazole Amoxicillin Amoxicillin sodium Clarithromycin

U.S. FDA Resources

Groups and Cohorts

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	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

Outcome Measures

Primary Outcome Measures :

Helicobacter pylori eradication rate [ Time Frame: 2 year ]
Number of participant with successful Helicobacter pylori eradication

Eligibility Criteria

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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

Study Population

Helicobacter-pylori positive patients with gastritis, ulcer, adenoma

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

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

Sponsors and Collaborators

Kangdong Sacred Heart Hospital

Investigators

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Principal Investigator:	Woon Geon Shin	Kangdong Sacred Heart Hospital

More Information

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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

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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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

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