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IRCT20240311061259N1 IRCT 2024-10-10 Shahid Beheshti University of Medical Sciences Comparing the effect of levofloxacin with metronidazole in the eradication of Helicobacter pylori Comparing the effectiveness of the four-drug regimen containing levofloxacin with the effectiveness of the four-drug regimen containing metronidazole in the treatment of Helicobacter pylori eradication 2024-10-06 anticipated 162 Complete https://irct.ir/trial/79249 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are assigned to two groups using the random block method. The number of blocks will be 22 and in each block, two, four or six patients will be included in the study order. Random allocation of blocks of patients to two intervention groups will be done through Sealed Envelope online software. By referring to https://www.sealedenvelope.com/simple-randomiser/v1/lists by specifying the total number of samples, the number of possible samples in each randomized block (2, 4 and 6 patients) randomization by online software is done For example, like the following output: block identifier block size sequence within block treatment 1 2 1 Group B 1 2 2 Group A 2 4 1 Group A 2 4 2 Group B 2 4 3 Group B 2 4 4 Group A 3 2 1 Group A 3 2 2 Group B ... which is the block number, the number of patients in the block, and the random assignment of each patient (with the corresponding number) to the treatment group. The randomized list of blocks will be placed in sealed envelopes and will be provided to the gastroenterologist on a daily basis. 3 Helicobacter pylori. Intervention 1: Intervention group: Receiving quadruple therapy of omeprazole, bismuth, amoxicillin and levofloxacin. Intervention 2: Intervention group: receiving quadruple therapy of omeprazole, bismuth, amoxicillin and metronidazole. No - There is not a plan to make this available Justification or reason for not sharing IPD is Protecting patients' privacy and confidentiality
public Mahshid Malekian
Arabi street, Velenjak
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2243 2525 mahshidmalekian2023@gmail.com Shahid Beheshti University of Medical Sciences scientific Amir Sadeghi
Arabi street, Velenjak
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2243 2525 amirsadeghimd@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) positive helicobacter pylori 18 years 70 years Both History of previous eradication therapy for Helicobacter pylori History of gastrectomy Stomach malignancy (including adenocarcinoma and lymphoma) Use of antibiotics (amoxicillin, clarithromycin, tinidazole) in the last four weeks B96.81 Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere Treatment - Drugs Treatment - Drugs Intervention group: Receiving quadruple therapy of omeprazole, bismuth, amoxicillin and levofloxacin Intervention group: receiving quadruple therapy of omeprazole, bismuth, amoxicillin and metronidazole Helicobacter pylori eradication. Timepoint: Before the intervention and 14 days after the intervention. Method of measurement: stool antigen test. Side effect of drugs. Timepoint: During the intervention and after the completion of the intervention. Method of measurement: History and clinical examination. Shahid Beheshti University of Medical Sciences Approved 2024-08-20 Ethics Committee in Biomedical Research, Gastroenterology and Liver Research Institute, Shahid Behes Arabi street, Velenjak Tehran Tehran Iran (Islamic Republic of)