Optimized-dose Amoxicillin Versus Standard-dose Amoxicillin for Quadruple Therapy in Helicobacter Pylori Eradication

• Status: Completed
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this prospective randomized clinical trial is to compare the rate of Helicobacter Pylori (HP) eradication after standard or dose-optimized amoxicillin quadritherapy in patients naïve to any anti-HP treatment and with chronic HP infection documented by histological examination. The main questions it aims to answer are:

• compare the eradication rate of H.Pylori after a standard concomitant quadritherapy with 2g of amoxicillin versus an optimized quadritherapy with 3g of amoxicillin, in Tunisian population

• Identify different factors associated with poor therapeutic response Patients were randomly assigned to either standard quadruple therapy (Qs-14: amoxicillin 1g twice daily, clarithromycin 500mg twice daily, metronidazole 500mg twice daily and esomeprazole 40mg twice daily for 14 days), or optimized quadruple therapy (Qo-14: amoxicillin 1g three times a day, clarithromycin 500mg twice daily, metronidazole 500mg twice daily and esomeprazole 40mg twice daily for 14 days). Eradication control was performed by urea breath test.

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

Details

• Lead Sponsor: Les Laboratoires des Médicaments Stériles

Criteria

Inclusion Criteria:

• H. pylori infection documented by pathological examination of per endoscopic gastric biopsies.

Exclusion Criteria:

• Previously received H.Pylori eradication therapy. Known allergy to one of the components of the kit used (Helikit) for 13C-urea breath test (UBT).

• A contraindication to 13C-UBT. Allergy or contraindication to the following antibiotics: Amoxicillin, Clarithromycin, Metronidazole and quinolones.

• Received antibiotics during the four weeks, or proton pump inhibitors (PPIs) during the two weeks prior to inclusion in the study.

• A history of bariatric surgery. Active gastro intestinal bleeding.

• Severe comorbidity such as decompensated cirrhosis, end-stage renal disease, decompensated cardiac disease and neoplastic disease.

• Patients on long-term immunosuppressive or corticosteroid therapy at a dose greater than 20mg/day.

• Pregnant or lactating women.