NCT04769583

14-day Quadruple Therapy Versus Triple Therapy in HP Eradication

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: mohamed bouchoucha · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Gastritis H Pylori

Interventions

Type	Name	Description
DRUG	metronidazole based quadriple therapy	patient randomized in QC will be treated by a double dose PPI (esomeprazole: 40 mg x 2 per day) in combination with amoxicillin (1 g x 2 per day), metronidazole (500 mg x 2 per day) and clarithromycin (500 mg x 2 per day)
DRUG	placebo based quadriple therapy	patient randomized in TT will be treated by double dose PPI (esomeprazole: 40 mg x 2 per day) in combination with amoxicillin (1 g x 2 per day), clarithromycin (500 mg x 2 per day) and a placebo of metronidazole.

Timeline

• Start date: 2019-02-10
• Primary completion: 2020-02-17
• Completion: 2020-03-05
• First posted: 2021-02-24
• Last updated: 2021-02-24

Locations

1 site across 1 country: Tunisia