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Effect of the CYP2C19 Polymorphism in Helicobacter Pylori Eradication

NCT03650543 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2018-08-28

No results posted yet for this study

Summary

Background: Triple therapy efficacy against Helicobacter pylori is low worldwide, thus alternatives must be sought to improve eradication. Aim: To determine CYP2C19 genetic polymorphism effect on H. pylori eradication.

Methods: A randomized single blinded clinical trial including 133 patients was carried-out. H. pylori infection was confirmed by histology and microbiological test. Antibiotic susceptibility to amoxicillin and clarithromycin was performed to avoid confusion bias in analysis results. CYP2C19 polymorphism "asterisk" \*1, "asterisk"\*2 and "asterisk" \*3 was analyzed by Real time PCR (Roche ®), and nested PCR for CYP2C19 "asterisk" \*17 polymorphism. Participants were randomized into two groups for different H. pylori therapies, one with standard omeprazole doses and another with omeprazole doses depending on CYP2C19 polymorphism. H. pylori eradicating was verified by stool antigen testing (Meridian ®). The general results was analysis by statistical computer program and the effectiveness of each therapy was analyzed by intention to treat (ITT) and by protocol (PP).

The study allowed to know the prevalence of the main polymorphisms of CYP2C19 in Bogotá-Colombia, also allowed to know the effectivenesses of the two therapies evaluated for H. pylori infection. Additionally, the importance of personalized medicine in H. pylori eradication therapy was known.

Conditions

  • CYP2C19 Polymorphism
  • H.Pylori Infection
  • Therapy

Interventions

DRUG

amoxicillin clarithromycin omeprazole 1

Patients in this received triple standard therapy for eradication of H.pylori with standard doses of proton pump inhibitor (omeprazole), in combination with amoxicillin and clarithromycin in absence of antibiotic resistance.

DRUG

amoxicillin clarithromycin omeprazole 2

The treatment for patients in this group was prescribing triple standard therapy for H.pylori eradication with amoxicillin and clarithromycin in absence of antibiotic resistance but with different doses of proton pump inhibitor (omeprazole) according to CYP2C19 genotype in each patients.

Sponsors & Collaborators

  • Universidad Nacional de Colombia

    collaborator OTHER

  • Javeriana University

    lead OTHER

Principal Investigators

  • Alba Alicia Trespalacios Rangel, Ph.D · Pontificia Universidad Javeriana

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-09-10
Primary Completion
2015-08-08
Completion
2015-08-08

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03650543 on ClinicalTrials.gov