Effect of Triple Versus Quadruple Therapy for Treating Helicobacter Pylori Infection

NCT07010744 — Not applicable, Enrolling by invitation, 66 participants, Akil Al Islam

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

Registry	NCT07010744
Status	Enrolling by invitation
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	66 (Estimated)
Sponsor	Akil Al Islam (Other)
Conditions	Dyspepsia
Interventions	Triple drug regimen, Quadruple therapy (Drug)
Dates	start 2025-07-01, primary completion 2026-06-01 (estimated), completion 2026-06-01 (estimated), first posted 2025-06-08, last updated 2026-05-07
Locations	1 site in Bangladesh

-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.

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

+Arms and interventions

Arm	Type	Interventions	Description
Triple drug Therapy	Experimental	Drug: Triple drug regimen	Triple drug therapy includes Amoxicillin , clarithromycin and esomeprazole
Quadruple therapy	Experimental	Drug: Quadruple therapy	Bismuth Metronidazole Tetracycline Esomeprazole

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

+Outcome measures

Primary outcomes

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

Secondary outcomes

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]

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Dhaka Medical College	Dhaka	Bangladesh

+Investigators

Akil Al Islam, MBBS,MRCP, Principal investigator, Dhaka Medical College