Addition of Nitazoxanide to Standard Clarithromycin Based Triple Therapy for 2 Weeks Effectively Eradicates Treatment-Naive Helicobacter Pylori Infection. A Single Centre prospective, open-label study

BACKGROUND: The increasing prevalence of antibiotic-resistant strains of Helicobacter pylori (H. pylori) led to reduced success with traditional H. pylori treatments. This warrants further evaluation of other treatment options. One such treatment regimen of interest is nitazoxanide containing regimen. In this study, we evaluated the efficacy of the addition of nitazoxanide to clarithromycin-based triple therapy in patients with H. pylori infection. METHODS: In this single-center prospective observational trial, patients with H. pylori infection were treated with a regimen comprising of nitazoxanide 1000 mg, amoxicillin 2000 mg, clarithromycin 1000 mg, and esomeprazole 80 mg per day (NACE regimen) for14 days. Eradication of H. pylori infection was assessed 4 weeks after completion of therapy by using stool antigen assay. Treatment compliance and adverse effects were also evaluated. RESULTS: Out of 111 patients who entered into the study for final analysis, H. pylori eradication was achieved in 93.7% (104 out of 111) patients in per-protocol analysis and 90.4% (104 out of 115) patients in intention to treat analysis. The treatment regimen was well tolerated. CONCLUSION: The addition of nitazoxanide to standard clarithromycin-based triple therapy effectively eradicates H. pylori infection. This regimen is safe and well tolerated.