14-day Quadruple Therapy Versus Triple Therapy in HP Eradication — HEPRA  

Gastritis H Pylori Clinical Trial

Official title: A Double Blind Randomized Study for Treatment of Helicobacter Pylori Infection: 14-day Non-bismuth Quadruple Therapy Versus Triple Therapy.

Status Completed

Clinical Trial Summary

In this prospective randomized-controlled study, treatment-naive H. pylori-infected patients are randomized to receive either standard triple therapy or sequential therapy. The aim is to compare the efficacy of concomitant quadruple therapy with standard triple therapy as a first line treatment for H. pylori infection in Tunisian patients.

Clinical Trial Description

This study includes male and female patients aged between 18 and 65, with documented Hp infection and who have had no previous eradication treatment.The diagnosis of Hp infection was made through an anatomopathological study. Gastric biopsies were taken according to the Sydney protocol: two fundics in one pot, two antrals and one at the angle of the lesser curve in a second pot. The biopsies were studied by an experienced anatomopathologist.

The included patients were randomly divided into two treatment groups according to a 1: 1 ratio: the first group received concomitant quadruple therapy (QC) combining a double dose PPI (esomeprazole: 40 mg x 2 per day) with the amoxicillin (1 g x 2 per day), metronidazole (500 mg x 2 per day) and clarithromycin (500 mg x 2 per day) for 14 days. The second group received triple therapy (TT) combining a double dose PPI (esomeprazole: 40 mg x 2 per day) with amoxicillin (1 g x 2 per day) and clarithromycin (500 mg x 2 per day) for 14 days.

H. pylori eradication was assessed by the 13C-urea breath test 8 weeks after treatment. ;

Related Conditions & MeSH terms

• Gastritis
• Gastritis H Pylori

• NCT number: NCT04769583
• Study type: Interventional
• Source: Les Laboratoires des Médicaments Stériles
• Status: Completed
• Phase: Phase 4
• Start date: February 10, 2019
• Completion date: March 5, 2020