Ondansetron treatment reduces rotavirus symptoms-A randomized double-blinded placebo-controlled trial

PLoS One. 2017 Oct 27;12(10):e0186824. doi: 10.1371/journal.pone.0186824. eCollection 2017.

Abstract

Background: Rotavirus and norovirus cause acute gastroenteritis with severe diarrhoea and vomiting, symptoms that may lead to severe dehydration and death. The objective of this randomized double-blinded placebo-controlled study was to investigate whether ondansetron, a serotonin receptor antagonist could attenuate rotavirus- and norovirus-induced vomiting and diarrhoea, which would facilitate oral rehydration and possibly accelerate recovery and reduce need for hospitalization.

Methods: Children with acute gastroenteritis, aged 6 months to 16 years where enrolled (n = 104) and randomized to one single oral dose (0.15mg/kg) of ondansetron (n = 52) or placebo (n = 52). The number of diarrhoea and vomiting episodes during the 24 hours following treatment was reported as well as the number of days with symptoms. Pathogens in faeces were diagnosed by real-time PCR. Outcome parameters were analyzed for rotavirus- and norovirus-positive children.

Results: One dose of oral ondansetron reduced duration of rotavirus clinical symptoms (p = 0.014), with a median of two days. Furthermore, ondansetron reduced diarrhea episodes, most pronounced in children that had been sick for more than 3 days before treatment (p = 0.028).

Conclusion: Ondansetron may be a beneficial treatment for children with rotavirus gastroenteritis.

Trial registration: European Clinical Trial Database EudraCT 2011-005700-15.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Antidiarrheals / adverse effects
  • Antidiarrheals / therapeutic use*
  • Antiemetics / adverse effects
  • Antiemetics / therapeutic use*
  • Child
  • Child, Preschool
  • Double-Blind Method
  • Female
  • Humans
  • Infant
  • Male
  • Ondansetron / adverse effects
  • Ondansetron / therapeutic use*
  • Placebos
  • Prospective Studies
  • Rotavirus Infections / drug therapy*

Substances

  • Antidiarrheals
  • Antiemetics
  • Placebos
  • Ondansetron

Grants and funding

This study was supported by the research funder Swedish Research Council (LS) 320301, URL: http://www.vr.se/. This study is an academic study; professor Lennart Svensson is the sponsor and he is supported by the Swedish Research Council.