Therapy Clinical Trial
Official title:
Effect of the CYP2C19 Polymorphism in Helicobacter Pylori Eradication
Verified date | August 2018 |
Source | Javeriana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 133 |
Est. completion date | August 8, 2015 |
Est. primary completion date | August 8, 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 19 Years to 70 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Javeriana University | Universidad Nacional de Colombia |
Arévalo-Galvis A, Trespalacios-Rangell AA, Otero W, Mercado-Reyes MM, Poutou-Piñales RA. Prevalence of cagA, vacA, babA2 and iceA genes in H. pylori strains isolated from Colombian patients with functional dyspepsia. Pol J Microbiol. 2012;61(1):33-40. — View Citation
Baldwin RM, Ohlsson S, Pedersen RS, Mwinyi J, Ingelman-Sundberg M, Eliasson E, Bertilsson L. Increased omeprazole metabolism in carriers of the CYP2C19*17 allele; a pharmacokinetic study in healthy volunteers. Br J Clin Pharmacol. 2008 May;65(5):767-74. doi: 10.1111/j.1365-2125.2008.03104.x. Epub 2008 Feb 20. — View Citation
Chaudhry AS, Kochhar R, Kohli KK. Genetic polymorphism of CYP2C19 & therapeutic response to proton pump inhibitors. Indian J Med Res. 2008 Jun;127(6):521-30. Review. — View Citation
Furuta T, Graham DY. Pharmacologic aspects of eradication therapy for Helicobacter pylori Infection. Gastroenterol Clin North Am. 2010 Sep;39(3):465-80. doi: 10.1016/j.gtc.2010.08.007. Review. — View Citation
Furuta T, Shirai N, Sugimoto M, Nakamura A, Hishida A, Ishizaki T. Influence of CYP2C19 pharmacogenetic polymorphism on proton pump inhibitor-based therapies. Drug Metab Pharmacokinet. 2005 Jun;20(3):153-67. Review. — View Citation
Furuta T, Sugimoto M, Shirai N, Ishizaki T. CYP2C19 pharmacogenomics associated with therapy of Helicobacter pylori infection and gastro-esophageal reflux diseases with a proton pump inhibitor. Pharmacogenomics. 2007 Sep;8(9):1199-210. Review. — View Citation
Graham DY, Shiotani A. New concepts of resistance in the treatment of Helicobacter pylori infections. Nat Clin Pract Gastroenterol Hepatol. 2008 Jun;5(6):321-31. doi: 10.1038/ncpgasthep1138. Epub 2008 Apr 29. Review. — View Citation
Isaza C, Henao J, Martínez JH, Sepúlveda Arias JC, Beltrán L. Phenotype-genotype analysis of CYP2C19 in Colombian mestizo individuals. BMC Clin Pharmacol. 2007 Jul 11;7:6. — View Citation
Li-Wan-Po A, Girard T, Farndon P, Cooley C, Lithgow J. Pharmacogenetics of CYP2C19: functional and clinical implications of a new variant CYP2C19*17. Br J Clin Pharmacol. 2010 Mar;69(3):222-30. doi: 10.1111/j.1365-2125.2009.03578.x. Review. — View Citation
Sapone A, Vaira D, Trespidi S, Perna F, Gatta L, Tampieri A, Ricci C, Cantelli-Forti G, Miglioli M, Biagi GL, Paolini M. The clinical role of cytochrome p450 genotypes in Helicobacter pylori management. Am J Gastroenterol. 2003 May;98(5):1010-5. — View Citation
Scott D, Weeks D, Melchers K, Sachs G. The life and death of Helicobacter pylori. Gut. 1998 Jul;43 Suppl 1:S56-60. Review. — View Citation
Sugimoto M, Furuta T, Shirai N, Kodaira C, Nishino M, Ikuma M, Ishizaki T, Hishida A. Evidence that the degree and duration of acid suppression are related to Helicobacter pylori eradication by triple therapy. Helicobacter. 2007 Aug;12(4):317-23. — View Citation
Sugimoto M, Furuta T. Efficacy of tailored Helicobacter pylori eradication therapy based on antibiotic susceptibility and CYP2C19 genotype. World J Gastroenterol. 2014 Jun 7;20(21):6400-11. doi: 10.3748/wjg.v20.i21.6400. Review. — View Citation
Tang HL, Li Y, Hu YF, Xie HG, Zhai SD. Effects of CYP2C19 loss-of-function variants on the eradication of H. pylori infection in patients treated with proton pump inhibitor-based triple therapy regimens: a meta-analysis of randomized clinical trials. PLoS One. 2013 Apr 30;8(4):e62162. doi: 10.1371/journal.pone.0062162. Print 2013. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Gender | percentage of male and female | through study completion an average of 3 years | |
Other | Weight | Kilograms | through study completion an average of 3 years | |
Other | Height | centimeters | through study completion an average of 3 years | |
Other | Body mass index | kg/m^2 | through study completion an average of 3 years | |
Other | Prevalence of CYP2C19 polymorphism | Percentage | through study completion an average of 3 years | |
Other | Adverse effects in each therapy | Percentage | through study completion an average of 3 years | |
Primary | Effectiveness of each therapy by protocol (PP) | Percentage | through study completion an average of 3 years | |
Secondary | Effectiveness of each therapy by intention to treat (ITT) | Percentage | through study completion an average of 3 years |
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