NCT07312721

Comparative Effectiveness of Triple Versus Quadruple Therapy in the Treatment of Helicobacter Pylori Induced Gastritis

Comparative Effectiveness of Triple Versus Quadruple Therapy in the Treatment of Helicobacter Pylori Induced Gastritis: A Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 752 (actual)
• Sponsor: Azfar Farogh · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This randomized controlled trial is designed to compare the efficacy of standard triple therapy versus bismuth-based quadruple therapy for the eradication of Helicobacter pylori-induced gastritis. The study is being conducted at Shahida Islam Medical College, Lodhran, Pakistan. Adult patients with confirmed H. pylori infection are randomly allocated to receive either a 14-day triple therapy regimen or a 14-day bismuth-based quadruple therapy regimen. Eradication of H. pylori is assessed six weeks after completion of treatment using stool antigen testing. The primary outcome measure is the proportion of patients achieving successful eradication of H. pylori.

Detailed description

Background: Helicobacter pylori infection is a major cause of chronic gastritis, peptic ulcer disease, and gastric malignancy. Standard triple therapy has historically been used as first-line treatment; however, increasing antibiotic resistance has led to declining eradication rates in many regions. Bismuth-based quadruple therapy has emerged as an alternative regimen and is recommended in areas with suspected or confirmed antibiotic resistance. Objective: To compare the efficacy of standard triple therapy versus bismuth-based quadruple therapy in achieving eradication of Helicobacter pylori in adult patients with H. pylori-induced gastritis. Study Design and Methods: This is a randomized controlled trial conducted in the Department of Medicine at Shahida Islam Medical College, Lodhran, Pakistan. Adult patients aged 18 to 65 years with confirmed H. pylori infection based on stool antigen testing are eligible for inclusion. Participants are randomly assigned in a 1:1 ratio to one of two treatment groups. One group receives standard triple therapy consisting of omeprazole, amoxicillin, and clarithromycin for 14 days. The second group receives bismuth-based quadruple therapy consisting of omeprazole, metronidazole, tetracycline, and bismuth subsalicylate for 14 days. Patients are followed for six weeks after completion of therapy. Eradication of H. pylori is evaluated using repeat stool antigen testing. The primary outcome measure is successful eradication of H. pylori. Secondary analyses include assessment of eradication outcomes across demographic and clinical subgroups. Ethical Approval: The study protocol has been approved by the Institutional Review Board of Shahida Islam Medical College (IRB No. SIMC/ETC/0008/24, dated 05 January 2024). Written informed consent is obtained from all participants prior to enrollment.

Conditions

• Helicobacter Pylori Infection
• Chronic Gastritis
• Peptic Ulcer Disease

Interventions

Type	Name	Description
DRUG	Triple Therapy	Omeprazole 40 mg BID, Amoxicillin 1 g BID, Clarithromycin 500 mg BID for 14 days.
DRUG	Quadruple Therapy	Omeprazole 40 mg BID, Metronidazole 400 mg TID, Tetracycline 500 mg QID, Bismuth subsalicylate for 14 days.

Timeline

• Start date: 2024-01-05
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2025-12-31
• Last updated: 2025-12-31

Locations

1 site across 1 country: Pakistan