Comparison of the efficacy of the amoxicillin and pantoprazole regimen with clarithromycin-based quadruple regimen for Helicobacter pylori eradication

Comparison the efficacy of the amoxicillin and pantoprazole regimen with clarithromycin-based quadruple regimen for Helicobacter pylori eradication

This clinical trial with parallel groups, double-blinded randomized, will be conducted on 166 in patients with positive H.pylori infection. Assignment of patients to the study groups will be done by random-numbers table and using computer

From patients with confirm diagnosis of H. pylori infection referring to Imam Khomeini hospital, Ahvaz, total of 166 patients will be selected and randomly divided into 2 groups. The patients and experimenters will not know about type of treatment and patient grouping

Inclusion criteria: Age above 18 years, confirm diagnosis of H. pylori infection by stool antigen test, no previous treatment of H. pylori infection, patient consent to participate in the study; Exclusion criteria: using antibiotics or nonsteroidal anti-inflammatory drugs (NSAIDs) in last 4 weeks, allergy to the studied drugs, history of gastric surgery or presence of a serious concomitant disease such as cancer, pregnant or lactating women

Intervention group (dual regimen): amoxicillin 1000 mg every 12 hours and pantoprazole 40mg every 12 hours for 14 days and then pantoprazole 40 mg every 12 hours for 4 weeks will be prescribed. Control group (quadruple regimen): clarithromycin 500 mg every12 hours, amoxicillin 1000mg every 12 hours, bismuth subcitrate 240 mg every 12 hours and pantoprazole 40 mg every 12 hours for 14 days and then pantoprazole 40 mg every 12 hours for 4 weeks will be prescribed.

Presence of Helicobacter pylori infection (based on stool antigen test) 2 weeks after the end of treatment and presence of any complication of medication (nausea, vomiting, and allergic reactions)

Patients will be assigned into two groups by simple randomization method. Allocation of patients to the study groups will be done by random-numbers table and using computer, and on this basis patients will be included in one of the two treatment groups. The implementation of the random allocation sequence occurs without knowledge of which patient will receive which treatment.

Intervention (receiving dual therapy regimen or clarithromycin-based quadruple regimen) and patient evaluation will be carried out by a physician who is blinded to placement in treatment groups. Also patients and statistical analyzer will not know about patient grouping.