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Enrolling by Invitation

NCT Number: NCT07010744

Effect of Triple Versus Quadruple Therapy for Treating Helicobacter Pylori Infection

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.

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Key information

Conditions

Dyspepsia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dhaka Medical College

Dhaka, 1000, Bangladesh

About this study

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 6 weeks later to evaluate eradication. Ethical approval will be obtained, and confidentiality will be maintained.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

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

    Time frame: 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

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Akil Al Islam

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 8, 2025
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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