14-day Quadruple Therapy Versus Triple Therapy in HP Eradication

Phase 4

Completed

• Conditions: Gastritis H Pylori
• Interventions: Drug: metronidazole based quadriple therapy; Drug: placebo based quadriple therapy

• Registration Number: NCT04769583
• Lead Sponsor: mohamed bouchoucha

Brief 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.

Study Timeline

• Study Start: 2019-02-10
• Primary Completion: 2020-02-17
• Study Completion: 2020-03-05
• Status Verified: 2021-02
• Study First Submitted: 2021-02-18
• Study First Submitted QC: 2021-02-23
• Last Update Submitted: 2021-02-23
• Study First Posted: 2021-02-24
• Last Update Posted: 2021-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

Inclusion Criteria

• patients aged between 18 and 65, with documented Hp infection.

Exclusion Criteria

are excluded patients:

• With Cirrhosis.
• With Renal failure (serum creatinine> 120 µmol / L).
• Having complicated peptic ulcer (stenosis or hemorrhage or perforation) in an acute phase.
• Having severe psychiatric disorders.
• Having had gastric surgery in their history.
• Having already received an HP eradication treatment.
• Having received an antibiotic within the last two weeks.
• Who are allergic to one of the antibiotics used in the anti-Hp cure.
• Who are drug addicted.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
concomitant quadruple therapy (QC)	metronidazole based quadriple therapy	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
triple therapy (TT)	placebo based quadriple therapy	PPI (esomeprazole: 40 mg x 2 per day) with amoxicillin (1 g x 2 per day) and clarithromycin (500 mg x 2 per day) AND PLACEBO for 14 days.

Primary Outcome Measures

Name	Time	Method
HP eradiction rate	6 weeks after completion of study treatment	assessment by breath test

Secondary Outcome Measures

Name	Time	Method
percentage of adverse reactions	3 months	we will determinate the percentage of adverse reactions in each group of treatment.

Trial Locations

Locations (1)

Fattouma Bourguiba Hospital; 🇹🇳 Monastir, Tunisia