Nitazoxanide Use as Part of an Empiric Multi-Drug Regimen in Treating Children with Suspected Helicobacter pylori Infection

Helicobacter pylori, a Gram-negative bacterium found in the human stomach, is often present in patients with chronic gastritis. Traditional treatment for H. pylori infection includes metronidazole or clarithromycin, both being associated with development of resistance. In this retrospective report, we describe our clinical experience using a multi-drug treatment regimen for pediatric H. pylori that included nitazoxanide, a newer nitrothiazole benzamide compound used in treating intestinal protozoa infections. Charts were identified for patients who were treated between January 1, 2008 and December 31, 2013 with an ICD-9-CM code 041.86 (H. pylori) and who underwent elective endoscopy. All patients were exposed to nitazoxanide for 3 days plus azithromycin, and cefixime (or another 3rd-generation oral cephalosporin) for 7-10 days, plus a proton pump inhibitor for 30 days. The clinical cure criteria were predefined. There were 127 individual occurrences or cases identified for inclusion in the review, with 111 occurrences meeting the inclusion criteria. The success rate or clinical cure for the new therapy combination prescribed as defined prior to the chart review was 99 out of 111 cases (89.2%). There were no serious adverse events observed or reported during the treatment of any patient. Approximately 10% of patient charts reflected minor complaints of nausea, vomiting or abdominal cramps during the time of active drug therapy. Nitazoxanide appears to be an effective and well-tolerated option for use in combination with other agents to treat H. pylori-induced gastritis.