Levofloxacin versus moxifloxacin in nitazoxanide-based quadruple therapy as a first-line treatment for Helicobacter pylori infection: NILE, a randomized, comparative, multicenter study

Abstract

Abstract Helicobacter pylori infection remains a major global health concern, with rising antibiotic resistance posing significant challenges to eradication efforts. The search for novel, effective regimens is particularly important in regions with high resistance rates to standard agents. This study evaluated the efficacy and safety of nitazoxanide-based quadruple therapies incorporating either levofloxacin or moxifloxacin. In this randomized, multicenter trial, treatment-naïve patients with confirmed H. pylori infection received standard triple therapy with amoxicillin, clarithromycin, and lansoprazole (ACL), levofloxacin–nitazoxanide–doxycycline–lansoprazole (LNDL) or moxifloxacin–nitazoxanide–doxycycline–lansoprazole (MNDL) for 14 days. Eradication was assessed by stool antigen testing. Rates were analyzed using intention-to-treat (ITT) and per-protocol (PP) methods. ITT eradication rates were 82.3% for the LNDL regimen, 71.8% for the MNDL regimen, and only 59.2% for the ACL regimen. Eradication with LNDL was were significantly higher than with ACL. PP analysis showed eradication rates of 87.2% for LNDL and 81.6% for MNDL, both significantly higher than ACL (60.9%). All regimens were well tolerated, with no serious adverse events reported. Fluoroquinolone-containing nitazoxanide-based quadruple regimens demonstrated superior eradication of H. pylori compared to clarithromycin-based triple therapy in treatment-naïve Egyptian patients. Although eradication rates did not reach the optimal threshold, these regimens represent practical alternatives when conventional regimens are not feasible. Trial registration: ClinicalTrials.gov Identifier: NCT05184491 registered on 11-01-2022.