Nitazoxanide in the treatment of viral gastroenteritis: a randomized double-blind placebo-controlled clinical trial

Aliment Pharmacol Ther. 2006 Nov 15;24(10):1423-30. doi: 10.1111/j.1365-2036.2006.03128.x.


Background: Enteric viruses including noroviruses and rotavirus are leading causes of diarrhoeal disease and gastroenteritis worldwide, and there is no effective treatment.

Aim: To evaluate nitazoxanide, a thiazolide anti-infective agent, in treating viral gastroenteritis in adults and adolescents.

Methods: 50 out-patients at least 12 years of age (mean 33.5 years) presenting with diarrhoea and stool-positive by enzyme-linked immunosorbent assay for norovirus, rotavirus or adenovirus were enrolled in a double-blind, placebo-controlled clinical trial. Patients were randomly assigned either nitazoxanide 500 mg or placebo twice daily for 3 days. The primary end point was time from first dose to resolution of symptoms. Analysis was modified intent-to-treat for 45 patients, excluding five patients with other identified enteropathogens at baseline.

Results: The median time from first dose to resolution of symptoms was 1.5 days (IQR: 0.5-2.5) for nitazoxanide-treated patients and 2.5 days (IQR: 1.5-4.5) for the placebo group. Significant reductions in time to resolution of symptoms were observed for all patients analysed (P < 0.0001) and for subsets of patients with rotavirus (P = 0.0052) and norovirus (P = 0.0295). The number of patients with adenovirus (n = 5) was too small to draw any conclusion. No significant adverse events were reported.

Conclusions: Nitazoxanide may play an important role in managing viral gastroenteritis in adults.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Anti-Infective Agents / therapeutic use*
  • Diarrhea / virology
  • Double-Blind Method
  • Gastroenteritis / drug therapy*
  • Gastroenteritis / virology
  • Humans
  • Middle Aged
  • Nitro Compounds
  • Thiazoles / therapeutic use*
  • Treatment Outcome
  • Virus Diseases / drug therapy*


  • Anti-Infective Agents
  • Nitro Compounds
  • Thiazoles
  • nitazoxanide