Efficacy of Amoxicillin-Esomeprazole HDDT Compared to Levofloxacin Triple Therapy for H. Pylori Eradication: A RCT

• Status: Recruiting
• Trial end date: 2024-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical trial is to compare the efficacy of two different therapeutic regimen for the treatment of Helicobacter pylori infected dyspeptic patients. The aim is -

1. To identify the percentage of H. pylori infection among dyspeptic patients

2. To compare the efficacy of amoxicillin-esomeprazole high dose dual therapy with levofloxacin containing triple therapy for the eradication of Helicobacter pylori.

Participants will be screened on the basis of two different test (stool antigen test & endoscopy with rapid urease test) to detect H. pylori infection. Who are positive on both tests will be finally enrolled in the study and randomized into two groups . one group will receive amoxicillin & esomeprazole for 14 days in higher dose. The other group will receive amoxicillin, levofloxacin & esomeprazole for 14 days in usual dose.

Dyspeptic symptoms will be recorded before & after treatment. Side effects of drugs will also be recorded. Finally 1 month after completion of treatment , H.pylori status will be cheeked by stool antigen test and results will be compared between two groups.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Treatments: Amoxicillin; Esomeprazole; Levofloxacin

Criteria

Inclusion Criteria:

1. Age ≥ 18 years

2. Dyspeptic patients with positive Rapid urease test & stool antigen test

3. patients giving written informed consent

Exclusion Criteria:

1. Treatment with proton pump inhibitor, H2-receptor antagonist, bismuth preparation within the last 2 weeks or antibiotics within 4 weeks prior to study.

2. Previous H. pylori eradication therapy

3. Complicated duodenal ulcer patients (active bleeding and perforation)

4. Patients with regular intake of NSAIDs or steroids.

5. Surgery that might affect gastric acid secretion (upper GI resection or vagotomy)

6. Known case of malignancy

7. Advanced Co-morbidities (e.g. CLD, CKD, cardio-respiratory failure, known thyroid disease)

8. participants who are pregnant, lactating or intend to become pregnant within the duration of the study.