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IRCT20240507061691N1 IRCT 2025-02-09 Mazandaran University of Medical Sciences Comparison of 3 or 4 times daily amoxicillin administration in a triple therapy for Helicobacter pylori eradication. Comparison of the effectiveness of administering amoxicillin 3 or 4 times daily in triple-drug regimens containing esomeprazole, bismuth, and amoxicillin for eradication of Helicobacter pylori in patients with this infection 2025-02-03 anticipated 200 Complete https://irct.ir/trial/79469 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation will be done by block method (Randomization Block) with a block size of four and using Sealed Envelope online software at the address https://www.sealedenvelope.com at an individual level and by an Biostatistician researcher who is a member of the research team. In this site, which is an online software for creating random allocation, the create list option is selected through the randomization menu, and then the required parameters such as groups A and B, the number of blocks, which is 4, and the total number of samples will be entered. And finally the random allocation list will be created. A sealed non-transparent envelope will be used for concealment. Researchers enroll eligible participants after the baseline assessment, then remove and open each envelope in the order that corresponds to the participant's initial assessment order, and assign the eligible participant to either the intervention group or the control group, Blinding description: In this study, the care provider, investigator, outcome assessor, and safety committee are the physicians who are implementing the plan and are not blinded to the prescribed medication regimen. The participant and data analyst are blinded. 3 Helicobacter Pylori Infection. Intervention 1: First intervention group: Patients in this group receive amoxicillin capsules (Farabi Company) 1 gram half an hour after breakfast, lunch and dinner; bismuth subcitrate tablets (Pursina Company) 240 mg half an hour before breakfast, lunch and dinner; and esomeprazole capsules (Abidi Company) 40 mg half an hour before breakfast and dinner for 14 days. Intervention 2: Second intervention group: Patients in this group receive amoxicillin capsules (Farabi Company) 750 mg half an hour after breakfast, lunch, dinner and late at night; bismuth subcitrate tablets (Pursina Company) 240 mg half an hour before breakfast, lunch and dinner; and esomeprazole capsules (Abidi Company) 40 mg half an hour before breakfast and dinner for 14 days. Yes - There is a plan to make this available What will be shared: After de-identifying the participants in the study, the information related to the results of the interventions as well as the possible side effects of the intervention will be published according to the method of the intervention. When: The access period starts 1 month after the results are published To whom: The data will be available only to researchers working in academic and scientific institutions Conditions: The data can be obtained only to compare and check the effect of different treatment regimens. The data related to the acceptance rate of different treatment regimens and the amount of side effects in each treatment regimen can be received. Where to obtain: masoud.hosseini@mazums.ac.ir How to obtain: After reviewing the request, the data will be sent within a maximum period of one week Comments:
public Masoud Hosseini
No. 12 ,Iranzamin Ave.,Amir Mazandarani Blvd.
Sari Iran (Islamic Republic of) 48156594411 +98 11 3337 7178 masoud.hosseini@mazums.ac.ir Mazandaran University of Medical Sciences scientific Hafez Tirgar Fakheri
No. 12 , Iranzamin Ave., Amir Mazandarani Blvd.
Sari Iran (Islamic Republic of) 4815659411 +98 11 3337 7178 hafezfakheri@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Subjects with dyspepsia who undergo endoscopy Biopsy during endoscopy confirms the presence of Helicobacter pylori For the first time, a Helicobacter pylori eradication regimen is prescribed for them. 18 years no limit Both Unwillingness to participate in the study Patients who are taking anticoagulants, corticosteroids or ketoconazole at the same time Patients who have a history of stomach surgery Patients who have a history of heart failure, lung disease, chronic kidney failure, liver disease (cirrhosis or chronic hepatitis for any reason) or a history of cancer Consumption of alcoholic beverages in any amount The presence of any type of malignancy History of drug sensitivity to the drugs of this study History of H. pylori eradication regimens at any time Pregnancy and breastfeeding B98.0 Helicobacter pylori [H.pylori] as the cause of diseases Treatment - Drugs Treatment - Drugs First intervention group: Patients in this group receive amoxicillin capsules (Farabi Company) 1 gram half an hour after breakfast, lunch and dinner; bismuth subcitrate tablets (Pursina Company) 240 mg half an hour before breakfast, lunch and dinner; and esomeprazole capsules (Abidi Company) 40 mg half an hour before breakfast and dinner for 14 days. Second intervention group: Patients in this group receive amoxicillin capsules (Farabi Company) 750 mg half an hour after breakfast, lunch, dinner and late at night; bismuth subcitrate tablets (Pursina Company) 240 mg half an hour before breakfast, lunch and dinner; and esomeprazole capsules (Abidi Company) 40 mg half an hour before breakfast and dinner for 14 days. Helicobacter pylori eradication rate in treatment groups. Timepoint: 4 weeks after completion of treatment. Method of measurement: Stool Helicobacter Pylori Antigen. Drug compliance rate in treatment groups. Timepoint: Fifteenth day from the start of treatment. Method of measurement: The medication bag is checked and if more than 90% of the medication has been consumed, it is considered excellent acceptance. Side effects in treatment groups. Timepoint: If during treatment (14 days) there are severe complications (drug complications prevent daily life), the patient will make a phone call to the clinical caregiver. If there are no severe complications, the patient will be visited on day 15 and complications will be assessed. Method of measurement: Phone calls and visit. Mazandaran University of Medical Sciences Approved 2024-03-04 Ethics committee of Imam Khomeini Hospital of Mazandaran University of Medical Sciencesf No. 12, Iranzamin Alley, Amir Mazandarani Ave., Sari Mazandaran Iran (Islamic Republic of)