Effect of Triple Versus Quadruple Therapy for Treating Helicobacter Pylori Infection

Akil Al Islam

Status: Invitation-only

Conditions: Dyspepsia

Treatments: Drug: Triple drug regimen; Drug: Quadruple therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07010744

IRB-DMC/2025/39

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All dyspeptic patients aged ≥18 years.
• Patients who will provide informed written consent and agree to follow-up at 4 weeks post-treatment.

Exclusion criteria

• Patients who have received prior H. pylori eradication therapy.
• Ingestion of antibiotics or proton pump inhibitor within the prior 4 weeks. Patient who will test negative either of CLO or Stool Antigen Test or both
• Patients with known allergies or intolerance to any of the study medications.
• Patients with alarm symptoms (e.g., unexplained weight loss, persistent vomiting, dysphagia).
• Patients with a history of gastric surgery.
• Pregnant or lactating women.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Triple drug Therapy

Experimental group

Description:

Triple drug therapy includes Amoxicillin , clarithromycin and esomeprazole

Treatment:

Drug: Triple drug regimen

Quadruple therapy

Experimental group

Description:

Bismuth Metronidazole Tetracycline Esomeprazole

Treatment:

Drug: Quadruple therapy