Adding Nitazoxanide to standard triple therapy improves eradication rate of Helicobacter Pylori in post covid-19 antibiotic resistant era: a single center open-label randomized controlled trial

Abstract

H. pylori is one of the most prevalent antibiotic-resistant bacteria worldwide. Clarithromycin-based triple therapy had achieved suboptimal cure rate. To evaluate safety and efficacy of adding nitazoxanide as adjuvant therapy to the standard clarithromycin-based therapy versus other standard clarithromycin-based triple therapies, a single-center phase 4 prospective superiority parallel open-label randomized controlled trial was done. Two hundred patients were included in the study and were randomly distributed into 4 groups: Group 1: 50 patients were treated by clarithromycin 500mg bid, amoxicillin1gm bid, omeprazole 20 mg bid for 14 days, Group 2: 50 patients were treated by clarithromycin 500mg bid, metronidazole 500mg bid bid, omeprazole 20 mg bid for 14 days, group 3: 50 patients were treated by clarithromycin 500mg bid, nitazoxanide 500mg bid bid, omeprazole 20 mg bid for 14 days, and group 4: 50 patients were treated by clarithromycin 500mg bid, amoxicillin1gm bid, nitazoxanide 500mg bid bid, omeprazole 20 mg bid for 14 days. All patients were assessed after 4 week post treatment. Our trial showed that patients in group 4 had achieved the highest eradications rate: N=42, 84% in intention to treat analysis (ITT), and 89.36% in per protocol (PP) analysis, followed by group 1 which achieved eradication rate of 64% in ITT and 69.56% in PP, while in group 3 the eradication rate was 56% in ITT, and 56.25% in PP, and finally, group 2 achieved the least eradication rate 36% in ITT and 40.90% in PP, with significant difference between the studied groups (P 0.01). Furthermore, adding nitazoxanide to standard clarithromycin based triple therapy is effective than other used triple regimens and could be used as a first-line regimen for the eradication of H. pylori.