Clinical trial NCT03650543: Effect of the CYP2C19 Polymorphism in Helicobacter Pylori Eradication
Official title: Effect of the CYP2C19 Polymorphism in Helicobacter Pylori Eradication
Conditions: CYP2C19 Polymorphism
H.Pylori Infection
Therapy
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.
Interventions:
description: 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.
name: amoxicillin clarithromycin omeprazole 1
other_name: Conventional therapy
Group 1
type: Drug
description: 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.
name: amoxicillin clarithromycin omeprazole 2
other_name: Group 2
Personalized therapy
type: Drug
Study arms:
design_group_description: 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.
design_group_title: amoxicillin clarithromycin omeprazole 1
design_group_type: Experimental
design_group_description: 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.
design_group_title: amoxicillin clarithromycin omeprazole 2
design_group_type: Experimental
Sponsor: Pontificia Universidad Javeriana
Collaborators: Universidad Nacional de Colombia
Drug name mappings:
name: 马来酸溴苯那敏/盐酸去氧肾上腺素
lang: CN
name: Brompheniramine Maleate/Phenylephrine Hydrochloride
lang: EN