Clinical trial NCT07010744: Effect of Triple Versus Quadruple Therapy for Treating Helicobacter Pylori Infection -an Open Label Randomized Controlled Trial
Official title: Effect of Triple Versus Quadruple Therapy for Treating Helicobacter Pylori Infection -an Open Label Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dyspepsia
Lead sponsor: Dhaka Medical College
Sponsor class: OTHER
First posted: 2025-06-08
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

1. All dyspeptic patients aged ≥18 years. 2. Patients with positive CLO test and Stool antigen test both. 3. Patients who will provide informed written consent and agree to follow-up at 4 weeks post-treatment.

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Exclusion Criteria:

1. Patients who have received prior H. pylori eradication therapy.
2. Ingestion of antibiotics or proton pump inhibitor within the prior 4 weeks.
3. Patients with known allergies or intolerance to any of the study medications. 4. Patients with alarm symptoms (e.g., unexplained weight loss, persistent vomiting, gastrointestinal bleeding, dysphagia).

5. Patients with a history of gastric surgery. 6. Pregnant or lactating women.

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Primary outcomes:
measure: To compare the eradication rate of Helicobacter pylori infection between quadruple therapy and triple therapy among dyspeptic patients
timeFrame: 1 month
Secondary outcomes:
measure: 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
timeFrame: 1 month
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Dhaka Medical College
Study officials:
References: