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Efficacy of Amoxicillin-Esomeprazole High Dose Dual Therapy Compared to Levofloxacin Containing Triple Therapy for the Eradication of Helicobacter Pylori in a Tertiary Care Hospital: A Single-blind Randomized Controlled Trial
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.
Details
| Lead sponsor | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh |
|---|---|
| Phase | Phase 4 |
| Status | UNKNOWN |
| Enrolment | 70 |
| Start date | 2023-02-10 |
| Completion | 2024-02 |
Conditions
- Helicobacter Pylori Infection
- Helicobacter Pylori Eradication
Interventions
- group A : Amoxicillin Esomeprazole HDDT
- group-B : Levofloxacin triple therapy
Primary outcomes
- To compare the efficacy of amoxicillin-esomeprazole HDDT therapy with levofloxacin triple therapy for the eradication of Helicobacter pylori — 1 month after completion of eradication therapy
Group A will receive amoxicillin-esomeprazole high dose dual therapy for 14 days. Group-B patients will receive levofloxacin containing triple therapy 14 days. 1 month after completion of therapy, fresh stool sample will be collected from all patients for repeat stool antigen test \& H. pylori eradication will be recorded for each group. Eradication rate will be compared between two groups.
Countries
Bangladesh