Efficacy and safety of nitazoxanide based quadruple regimen as first line therapy for treating Helicobacter pylori infected naïve patients.

Background: Eradication of H. pylori is a challenging issue in many parts of the world including Egypt.

Aim: To evaluate the safety and efficacy of adding nitazoxanide as an adjuvant drug to the standard clarithromycin-based regimen, a single-center phase 4 prospective superiority parallel open-label randomized controlled trial was conducted.

Methodology: Two hundred naïve H. pylori-positive patients were randomly distributed into 4 groups in ratio 1:1:1:1; Group 1: 50 patients were treated by clarithromycin 500mg bid, amoxicillin1gm bid, omeprazole 20 mg, Group 2: 50 patients were treated by clarithromycin 500mg bid, metronidazole 500mg bid, omeprazole 20 mg bid, group 3: 50 patients were treated by clarithromycin 500mg bid, nitazoxanide 500mg bid, omeprazole 20 mg bid, and group 4: 50 patients were treated by clarithromycin 500mg bid, amoxicillin1gm bid, nitazoxanide 500mg bid, omeprazole 20 mg bid. All patients were treated for 14 days and assessed 4 weeks after treatment.

Results: Adding nitazoxanide to standard clarithromycin based triple therapy achieved a high eradication rate of 84% in intention to treat analysis (ITT), and 89.36% in per protocol (PP) analysis with high significant p (0.01).

Conclusions: adding nitazoxanide as an adjuvant drug to the standard clarithromycin-based regimen is effective and could be used as a first line regimen in the eradication of H. pylori.