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IRCT20201007048956N1 IRCT 2020-11-09 Ahvaz University of Medical Sciences Treatment of Helicobacter pylori infection of the stomach Eradication Efficacy of high dose amoxicillin and PPI Compared with standard bismuth containing quadruple Therapy as a First Line Treatment of Helicobacter pylori 2019-08-25 anticipated 220 Complete https://irct.ir/trial/51538 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we will use the Restricted randomization method of block randomization. Blockage is usually used to balance the number of samples allocated to each of the studied groups. This feature helps researchers to equalize the number of samples allocated to each of the studied groups in cases where intermediate analyzes are required during the sampling process. All blocks are the same size, and in this two-group experiment we will have 6 blocks (including 3 participants in the intervention group and 3 participants in the control group). Random allocation software software is also used to randomize random sequence production software (Random allocation software). 3 helicobacter pylori infection. Intervention 1: Intervention group: amoxicillin 750mg QID and pantoprazole 40mg TDS for 14 days. Intervention 2: Control group:Bismuth containing Quadruple thrapy{ clarithromycin 500 mg and amoxicillin 1 g and bismuth 220mg all twice per day), a proton pump inhibitor (pantoprazole 40 mg twice daily) all for 14 days}. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is no answer
public Amin Sabbaghan
No.۲۸,soghrat Ave.,amaniye Town
Ahwaz Iran (Islamic Republic of) 6133944753 +98 61 3336 0421 Sabbaghanamin@yahoo.com Ahvaz University of Medical Sciences scientific Amin Sabbaghan
No.۲۸,soghrat Ave.,amaniye Town
Ahwaz Iran (Islamic Republic of) 6133944753 +98 61 3336 0421 Sabbaghanamin@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) chronic gastritis with or without healed duodenal or stomach ulcer H. pylori positive determined by Rapid UreaseTest or Urea Breath Test treatment-naive patients for eradication of H. pylori infection 18 years 70 years Both allergy to medications used in this clinical trial use of PPI, histamine H2-receptor antagonists, antibiotics, bismuth, or probiotics 4 weeks before initiating study pregnancy or breastfeeding B96.81 Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere Treatment - Drugs Treatment - Drugs Intervention group: amoxicillin 750mg QID and pantoprazole 40mg TDS for 14 days Control group:Bismuth containing Quadruple thrapy{ clarithromycin 500 mg and amoxicillin 1 g and bismuth 220mg all twice per day), a proton pump inhibitor (pantoprazole 40 mg twice daily) all for 14 days} Helicobacter pylori infection. Timepoint: 45 days after intervention. Method of measurement: stool antigen test of helicobacter pylori. Reduce the cost of treatment. Timepoint: 45 days. Method of measurement: Lower cost. Less drug side effects. Timepoint: 45 days. Method of measurement: Patient clinical sign. Ahvaz University of Medical Sciences Approved 2019-12-07 Ethics committee of ahwaz University of Medical Sciences Ground floor central organization of Ahwaz Jundishapur University,Glestan Street. Ahwaz Khouzestan Iran (Islamic Republic of)