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IRCT20250227064868N1 IRCT 2025-05-02 Shahre-kord University of Medical Sciences Comparison of the effectiveness of triple and quadruple therapy regimens for Helicobacter pylori eradication in patients with positive stool antigen test Comparison of the effectiveness of triple and quadruple therapy regimens for Helicobacter pylori eradication in patients with positive stool exam: A randomized, single-blind clinical trial study 2025-04-05 anticipated 126 Complete https://irct.ir/trial/82314 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this way, 126 cards, 63 of which have the letter A written on them and the other 63 have the letter B written on them, are placed in a jumbled envelope, and one card is drawn at random for each patient. The letter that appears on the card indicates the patient's treatment group, Blinding description: In this study, due to the impossibility of drug matching, blinding is not performed for participants. However, blinding is performed for healthcare personnel (physicians), data collectors, and outcome assessors, and to a lesser extent, the Data Safety and Monitoring Board and those preparing the manuscript. 3 H.pilory infection. Intervention 1: Intervention group: Treatment regimen A for 14 days containing PPI: Esomeprazole 40 mg BID (Abidi Pharmaceutical Company) - Amoxicillin: 1000 mg TDS (Subhan Pharmaceutical Company) - Bismuth Subcitrate: 120 mg BD (Subhan Pharmaceutical Company). Intervention 2: Intervention group: Treatment regimen B (Bismuth quadruple therapy (BQT) for 14 days) containing PPI: Esomeprazole 40 mg BID (Abidi Pharmaceutical Company) - Tetracycline: 500 mg QID (Subhan Pharmaceutical Company) - Metronidazole: 500 mg TDS (Subhan Pharmaceutical Company) - Bismuth Subcitrate: 120 mg QID (Subhan Pharmaceutical Company). 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 There is no additional information available.
public Ali Sanei Dehkordi
No 3,Faraz Apartment, third Ave, 106 Alley, Kashani Street
Shahrekord Iran (Islamic Republic of) 8817985896 +98 38 3222 8693 sanei@skums.ac.ir Shahre-kord University of Medical Sciences scientific Ali Sanei Dehkordi
No 3,Faraz Apartment, third Ave, 106 Alley, Kashani Street
Shahrekord Iran (Islamic Republic of) 8817985896 +98 38 3222 8693 sanei@skums.ac.ir Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Helicobacter pylori positive Patients with first attempt at Helicobacter pylori eradication Age over 18 years 18 years no limit Both previous treatment for Helicobacter pylori eradication pregnancy or breastfeeding previous treatment for eradication of Helicobacter pylori malignant neoplasms history of gastrectomy history of allergy or adverse reactions to the study drugs history of use of PPIs and Potassium-Competitive Acid Blockers in the 2 weeks prior to randomization hematological disease, central nervous system infection, infectious mononucleosis, glucose-galactose malabsorption, lactase deficiency, galactose intolerance, or torsades de pointes Concomitant use of drugs that may interact with the drugs in the present study Withdrawal of consent or failure to complete the final test follow-up Development of drug hypersensitivity or intolerable adverse effects B96.81 Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere Treatment - Drugs Treatment - Drugs Intervention group: Treatment regimen A for 14 days containing PPI: Esomeprazole 40 mg BID (Abidi Pharmaceutical Company) - Amoxicillin: 1000 mg TDS (Subhan Pharmaceutical Company) - Bismuth Subcitrate: 120 mg BD (Subhan Pharmaceutical Company) Intervention group: Treatment regimen B (Bismuth quadruple therapy (BQT) for 14 days) containing PPI: Esomeprazole 40 mg BID (Abidi Pharmaceutical Company) - Tetracycline: 500 mg QID (Subhan Pharmaceutical Company) - Metronidazole: 500 mg TDS (Subhan Pharmaceutical Company) - Bismuth Subcitrate: 120 mg QID (Subhan Pharmaceutical Company) The eradication rate of Helicobacter pylori, which is defined as a negative stool antigen test. Timepoint: The stool antigen test is performed at the beginning of the study (before the intervention as an inclusion criterion) and four weeks after the completion of treatment. Method of measurement: Stool Antigen Test. Adherence to treatment. Timepoint: Four weeks after the completion of treatment. Method of measurement: Direct questioning of the patient and writing on the checklist. The clinical symptoms of patients (pain, bloating, appetite, heartburn) and the incidence of side effects during treatment as reported by the patients. Timepoint: After the completion of treatment. Method of measurement: Direct questioning of the patient and writing on the checklist. Shahre-kord University of Medical Sciences Approved 2024-07-31 Ethics committee of Shahrekord Univercity of Medical Sciences Kashani Blvd Sharekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)