Effect of Triple Versus Quadruple Therapy for Treating Helicobacter Pylori Infection

NCT07010744 | Enrolling By Invitation DMC

• 1 other identifier: IRB-DMC/2025/39
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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 subcitrate 120mg QDS, Tetracycline 500mg QDS and Metronidazole 500mg TDS. Patient will be confirmed H pylori eradication 4 weeks after completion of treatment by Stool antigen test only.

Conditions

Dyspepsia

Outcome Measures

Primary Outcomes (1)

• To compare the eradication rate of Helicobacter pylori infection between quadruple therapy and triple therapy among dyspeptic patients

  1 month

Secondary Outcomes (1)

• 1. To determine the eradication rate of H. pylori in patients receiving triple drug therapy. 2. To determine the eradication rate of H. pylori in patients receiving quadruple therapy. 3. Assess and quantify patient reported adverse events in both groups

  1 month

Study Arms (2)

Triple drug Therapy

EXPERIMENTAL

Triple drug therapy includes Amoxicillin , clarithromycin and esomeprazole

Drug: Triple drug regimen

Quadruple therapy

EXPERIMENTAL

Bismuth Metronidazole Tetracycline Esomeprazole

Drug: Quadruple therapy

Interventions

Triple drug regimen DRUG

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

Triple drug Therapy

Quadruple therapy DRUG

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

Quadruple therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akil Al Islam: lead

Study Sites (1)

Dhaka Medical College

Dhaka, 1000, Bangladesh

Location

MeSH Terms

Conditions

Dyspepsia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Akil Al Islam, MBBS,MRCP

  Dhaka Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 8, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-01

Locations

BA (1)