This study is conducted to investigate whether the efficacy of single-dose triple therapy (Esomeprazole 40 mg, Tinidazole 1 g, and Levofluxacine 500 mg) for 14 days is superior to double-dose lansoprazole 30 mg, amoxicillin 1 g and clarithromycin 500 mg for 14 days in the treatment of H pylori infection.
Multiple regimens have been evaluated for H. pylori therapy in randomized controlled trials The treatment regimen that is selected must be effective, but considerations such as cost, side effects, and ease of administration should also be taken into account. Despite the number of studies, the optimal therapeutic regimen has not yet been defined. The regimen most commonly recommended for first line treatment of H. pylori is triple therapy with a PPI, amoxicillin and clarithromycin for 14 days. However, the multi-drug application is associated with remarkable side effects and it is not uncommon not to be able to complete a treatment course. Thus, treatment failure is associated with H. pylori strains that are resistant to the commonly used antibiotics. This study is conducted to investigate whether the efficacy of single-dose triple therapy (Esomeprazole 40 mg, Tinidazole 1 g, and Levofluxacine 500 mg) for 14 days is superior to double-dose lansoprazole 30 mg, amoxicillin 1 g and clarithromycin 500 mg for 14 days in the treatment of H pylori infection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
212
Patients in experimental group will receive the 14 day single dose of Nexium 40 mg daily
Patients in experimental group will receive the 14 day single dose regimen of Tinafas 1 g daily
Patients in experimental group will receive the 14 day single dose of Tavanex 500 mg daily
Ilam University of Medical Scienvc
Īlām, Iran
The rate of H.pylori eradication
Breath Urea Test
Time frame: 42 days after study completion
Drug Compliance
Interview
Time frame: within the first week after study completion
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Patients in active comparator group will receive the 14 day lansoprazole (Lanzol) 30 mg twice daily
Patients in active comparator group will receive the 14 day clarithromycin (Klacid) 500 mg twice daily twice daily
Patients in active comparator group will receive the 14 day amoxicillin (Iramox) 1 g twice daily