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IRCT20250426065481N1 IRCT 2025-05-27 Babol University of Medical Sciences Comparison of 5-day and 10-day levofloxacin based triple regimen to eradication of helicobacter pylori: An open-label randomized clinical trial Comparison of 5-day and 10-day levofloxacin based triple regimen to eradication of helicobacter pylori: An open-label randomized clinical trial 2025-05-20 anticipated 120 Complete https://irct.ir/trial/83369 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization Type: Simple randomization- Individual-level randomization Randomization Tool: Participants are randomly assigned to groups using a computer-generated randomization code. Allocation is performed automatically without stratification or blocking. patients are assigned to either 5-day or 10-day treatment groups based on the pre-generated randomization code. 3 Helicobacter pylori infection. Intervention 1: Intervention group: 5-day treatment group regimen: Amoxicillin: 1000 mg twice daily, Levofloxacin 500 mg once daily (Tavanex®, abidi pharma), Pantoprazole 40 mg twice daily (abidi Pharma) for 5 days. Intervention 2: Control group: 10-day treatment group regimen: Amoxicillin: 1000 mg twice daily, Levofloxacin 500 mg once daily (Tavanex®, Abidi pharma), Pantoprazole 40 mg twice daily (Abidi pharma) for 10 days. No - There is not a plan to make this available Justification or reason for not sharing IPD is No further information available.
public Amin Vahedi
No. 29, 1st Tabarestan alley, 16th Lale St, Basij Blvd
Amol Iran (Islamic Republic of) 4614863313 +98 11 4324 0633 Dr.aminvahedi@gmail.com Babol University of Medical Sciences scientific Amin Vahedi
No. 29, 1st Tabarestan alley, 16th Lale St, Basij Blvd
Amol Iran (Islamic Republic of) 4614863313 +98 11 4324 0633 Dr.aminvahedi@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) All individuals aged 18 to 60 with a histologically confirmed Helicobacter pylori infection The patient's consent to participate in the study 18 years 60 years Both Prior treatment for H. pylori eradication Severe and chronic medical conditions Pregnant women History of NSAID, antibiotic, or PPI use within the last 30 days Prior stomach surgery Severe kidney dysfunction [serum creatinine >2 mg/dL] Severe liver dysfunction Known hypersensitivity to levofloxacin, amoxicillin, or pantoprazole Gastric cancer B98.0 Helicobacter pylori [H.pylori] as the cause of diseases classified to other chapters Treatment - Drugs Treatment - Drugs Intervention group: 5-day treatment group regimen: Amoxicillin: 1000 mg twice daily, Levofloxacin 500 mg once daily (Tavanex®, abidi pharma), Pantoprazole 40 mg twice daily (abidi Pharma) for 5 days Control group: 10-day treatment group regimen: Amoxicillin: 1000 mg twice daily, Levofloxacin 500 mg once daily (Tavanex®, Abidi pharma), Pantoprazole 40 mg twice daily (Abidi pharma) for 10 days Helicobacter Pylori infection eradication. Timepoint: Five weeks after completing treatment (two weeks after stopping pantoprazole). Method of measurement: Helicobacter pylori stool antigen test. Adverse effect- Constipation. Timepoint: Before starting the study, 5 days after starting treatment, and at the end of treatment. Method of measurement: Ask the patient in person or by phone. Adverse effect- Diarrhea. Timepoint: Before starting the study, 5 days after starting treatment, and at the end of treatment. Method of measurement: Ask the patient in person or by phone. Adverse effect- Nausea. Timepoint: Before starting the study, 5 days after starting treatment, and at the end of treatment. Method of measurement: Ask the patient in person or by phone. Adverse effect- Vomiting. Timepoint: Before starting the study, 5 days after starting treatment, and at the end of treatment. Method of measurement: Ask the patient in person or by phone. Adverse effect- Abdominal pain. Timepoint: Before starting the study, 5 days after starting treatment, and at the end of treatment. Method of measurement: Ask the patient in person or by phone. Adverse effect- Heartburn. Timepoint: Before starting the study, 5 days after starting treatment, and at the end of treatment. Method of measurement: Ask the patient in person or by phone. Adverse effect- Metallic taste. Timepoint: Before starting the study, 5 days after starting treatment, and at the end of treatment. Method of measurement: Ask the patient in person or by phone. Adverse effect- Flatulence. Timepoint: Before starting the study, 5 days after starting treatment, and at the end of treatment. Method of measurement: Ask the patient in person or by phone. Adverse effect- Dizziness. Timepoint: Before starting the study, 5 days after starting treatment, and at the end of treatment. Method of measurement: Ask the patient in person or by phone. Adverse effect- Low appetite. Timepoint: Before starting the study, 5 days after starting treatment, and at the end of treatment. Method of measurement: Ask the patient in person or by phone. Adverse effect- Headache. Timepoint: Before starting the study, 5 days after starting treatment, and at the end of treatment. Method of measurement: Ask the patient in person or by phone. Adverse effect- Joint pain. Timepoint: Before starting the study, 5 days after starting treatment, and at the end of treatment. Method of measurement: Ask the patient in person or by phone. Adverse effect- Asthenia. Timepoint: Before starting the study, 5 days after starting treatment, and at the end of treatment. Method of measurement: Ask the patient in person or by phone. Stop treatment. Timepoint: At the end of treatment. Method of measurement: Ask the patient in person or by phone. Drug compliance. Timepoint: At the end of treatment. Method of measurement: Good drug compliance: more than 80% intake- Poor compliance: less than 80% intake. Ask the patient in person or by phone. Babol University of Medical Sciences Approved 2024-11-10 Research ethics committees of health research institute- Babol university of medical sciences Endoscopy ward, Ayatollah Rohani hospital, Ganj afrooz Ave Babol Mazandaran Iran (Islamic Republic of)