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Effect of the CYP2C19 Polymorphism in Helicobacter Pylori Eradication

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ClinicalTrials.gov Identifier: NCT03650543
Recruitment Status : Completed
First Posted : August 28, 2018
Last Update Posted : August 28, 2018
Sponsor:
Collaborator:
Universidad Nacional de Colombia
Information provided by (Responsible Party):
Azucena Arévalo Galvis, MSc, Javeriana University

Brief 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.


Condition or disease Intervention/treatment Phase
CYP2C19 Polymorphism H.Pylori Infection Therapy Drug: amoxicillin clarithromycin omeprazole 1 Drug: amoxicillin clarithromycin omeprazole 2 Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized single - blinded Clinical Trial conducted from 2012 to 2015 in Bogotá, Colombia. The aim was studying the effectiveness of triple therapy for H. pylori with amoxicillin, clarithromycin and standard dose of omeprazole versus amoxicillin, clarithromycin with dose of omeprazole according to CYP2C19 polymorphisms was studied, the subjects were allocated to a treatment regimen according to a randomized crossover sequence, provided by a computer-generated randomization list. Patients were contacted by telephone for assigned an appointment for treatment delivery according to the assigned group.
Masking: Single (Care Provider)
Masking Description: The mean masking was the treating Gastroenterologist doctor.
Primary Purpose: Treatment
Official Title: Effect of the CYP2C19 Polymorphism in Helicobacter Pylori Eradication
Actual Study Start Date : September 10, 2012
Actual Primary Completion Date : August 8, 2015
Actual Study Completion Date : August 8, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: amoxicillin clarithromycin omeprazole 1
This group received triple standard therapy with standard doses of omeprazole. 20 mg "omeprazole" before breakfast and before dinner. 500 mg "clarithromycin" after breakfast and after dinner and 1 g "amoxicillin" after breakfast and after dinner for 10 days.
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.
Other Names:
  • Conventional therapy
  • Group 1

Experimental: amoxicillin clarithromycin omeprazole 2
This group received triple standard therapy, using 500 mg "clarithromycin" after breakfast and after dinner and 1 g "amoxicillin" after breakfast and after dinner for 10 days in addition with "omeprazole" but "omeprazole" doses were prescribed according to CYP2C19 genotype as a follows: a) Patients with CYP2C19 *1/*1 genotype (Early and ultrarapid Metabolizer): 40mg "omeprazole" before breakfast and before dinner. b) Patients with CYP2C19 *1/*2 or *1/*3 genotype (Intermediate Metabolizer): 20mg "omeprazole" before breakfast, 20mg before lunch and 20mg before dinner. c) Patients with CYP2C19 *2/*2 (Poor Metabolizer): 20mg "omeprazole" before breakfast and 20 mg before dinner.
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.
Other Names:
  • Personalized therapy
  • Group 2




Primary Outcome Measures :
  1. Effectiveness of each therapy by protocol (PP) [ Time Frame: through study completion an average of 3 years ]
    Percentage


Secondary Outcome Measures :
  1. Effectiveness of each therapy by intention to treat (ITT) [ Time Frame: through study completion an average of 3 years ]
    Percentage


Other Outcome Measures:
  1. Gender [ Time Frame: through study completion an average of 3 years ]
    percentage of male and female

  2. Weight [ Time Frame: through study completion an average of 3 years ]
    Kilograms

  3. Height [ Time Frame: through study completion an average of 3 years ]
    centimeters

  4. Body mass index [ Time Frame: through study completion an average of 3 years ]
    kg/m^2

  5. Prevalence of CYP2C19 polymorphism [ Time Frame: through study completion an average of 3 years ]
    Percentage

  6. Adverse effects in each therapy [ Time Frame: through study completion an average of 3 years ]
    Percentage



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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects with functional dyspepsia or peptic ulcers
  • Subjects between the ages of 19 and 70 years old
  • Subjects who were referred for upper endoscopy, and had not received previous H. pylori eradication treatment within the last six months.
  • Subjects who had not received anti-secreting acid, bismuth or antibiotics for other diseases 15 days before the endoscopy.
  • For the study, only patients with sensitive isolates of H.pylori to amoxicillin and clarithromycin were included.

Exclusion Criteria:

  • Patients with serious comorbidities.
  • Pregnant women.
  • Patients allergic to the medications used in this study.

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): NCT03650543


Sponsors and Collaborators
Javeriana University
Universidad Nacional de Colombia
Investigators
Principal Investigator: Alba Alicia Trespalacios Rangel, Ph.D Pontificia Universidad Javeriana

Additional Information:
Publications:

Responsible Party: Azucena Arévalo Galvis, MSc, Bacteriologist, Javeriana University
ClinicalTrials.gov Identifier: NCT03650543     History of Changes
Other Study ID Numbers: 00004554
00004554 ( Other Grant/Funding Number: Pontificia Universidad Javeriana )
12010U80401200 ( Other Identifier: Pontificia Universidad Javeriana )
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Omeprazole
Amoxicillin
Clarithromycin
Proton Pump Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors