NCT07010744

Effect of Triple Versus Quadruple Therapy for Treating Helicobacter Pylori Infection

Effect of Triple Versus Quadruple Therapy for Treating Helicobacter Pylori Infection -an Open Label Randomized Controlled Trial

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Akil Al Islam · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Goal of this this clinical trial is to assess and compare the eradication rate of triple and quadruple therapy during treating helicobacter pylori infection among patients presented with dyspepsia. It will also assess the patient reported adverse events among two groups. H pylori infection will be confirmed by CLO (RUT) test and stool antigen test both. Standard triple therapy will be based on Esomeprazole 20 mg BD, Clarithromycin 500mg BD and Amoxicillin 1gm BD. Bismuth Quadruple therapy consists of Bismuth subsalicylate 300mg QDS, Tetracycline 500mg QDS and Metronidazole 400mg TDS. Patient will be confirmed H pylori eradication 4 weeks after completion of treatment by Stool antigen test only.

Detailed description

This Randomized Controlled Trial study aims to compare the eradication rates of Helicobacter pylori infection between quadruple therapy and triple therapy in dyspeptic patients at Dhaka Medical College \& Hospital. Sixty-Six participants, selected through purposive sampling, will be randomly allocated into two groups: 33 patients in Group A (receiving Triple therapy) and 33 in Group B (receiving Quadruple therapy). After pre-procedural preparation, a CLO test will be conducted during endoscopy and a stool antigen test to detect H. pylori. Participants will undergo treatment for 14 days, followed by follow-up testing 4 weeks later to evaluate eradication. Ethical approval will be obtained, and confidentiality will be maintained.

Conditions

• Dyspepsia

Interventions

Type	Name	Description
DRUG	Triple drug regimen	Amoxicillin 1000mg at 12 hourly for 14 days Clarithromycin 500mg at 12 hourly for 14 days Esomeprazole 20 mg at 12 hourly for 14 days
DRUG	Quadruple therapy	Bismuth subcitrate 120 mg at 6 hourly 14 days Metronidazole 500mg at 8 hourly 14 days Tetracycline 500mg at 6 hourly 14 days Esomeprazole 20 mg 12 hourly for 14 days

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2025-06-08
• Last updated: 2026-01-27

Locations

1 site across 1 country: Bangladesh