Nitazoxanide-based therapeutic regimen as a novel treatment for Helicobacter pylori infection in children and adolescents: a randomized trial

D. Shawky, A.M. Salamah, S.M. Abd-Elsalam, E. Habba, M.H. Elnaggar, A.A. Elsawy, N. Baiomy, M.M. Bahaa, R.M. Gamal

Department of Pediatrics, Faculty of Medicine, Tanta University, Tanta, Egypt. sherif.abdelbaky@med.tanta.edu.eg

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• Gastroenterology
• Microbiology

OBJECTIVE: Antibiotic resistance and poor patient compliance with treatment cause Helicobacter pylori to show increased resistance to typical first-line therapeutic regimens. This study aimed to evaluate the efficacy of the new nitazoxanide-based treatment regimens for Helicobacter pylori infection vs. the current metronidazole-based regimens to address the problem of increasing metronidazole resistance.

PATIENTS AND METHODS: This randomized clinical trial enrolled 100 patients with Helicobacter pylori infection. The patients were randomly assigned to one of two groups: group I received nitazoxanide-based triple therapy (nitazoxanide, proton pump inhibitor, and clarithromycin) for 14 days, whereas group II received standard treatment (metronidazole, omeprazole, and clarithromycin) for 14 days. On enrollment and after six weeks of treatment, all patients underwent careful history taking, full clinical examination, laboratory investigations (complete blood count, liver and renal function tests), and Helicobacter pylori stool antigen testing.

RESULTS: Of the patients, 92% in the nitazoxanide group and 84% in the metronidazole group recovered from infection, with no statistically significant difference between the two groups. Patients in the nitazoxanide group showed a 54% lower risk of resistant infection (odds ratio, 0.5; 95% confidence interval, 0.161-1.555) than those in the metronidazole group.

CONCLUSIONS: The nitazoxanide-based therapeutic regimen produced higher eradication rates than the standard treatment. However, the difference was not substantial in this particular group of patients.

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