NCT01087892

Probiotics in Preventing Antibiotic Associated Diarrhoea Including Clostridium Difficile Infection

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,126 (actual)
• Sponsor: University of Sussex · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

Antibiotics are currently required to treat patients in hospital when they have an infection, but these antibiotics can cause side effects such as diarrhoea and in some patients a serious form of gut infection with an organism called Clostridium difficile. This organism can produce toxins in the gut causing a severe form of diarrhoea associated with a lot of ill health, and in some circumstances can be fatal. Some studies have shown that yogurts' or Probiotics' (special drinks with a defined concentration of useful bacteria) taken by patients can have a beneficial effect in reducing the diarrhoea associated with antibiotics use. The aim of the present study is to find out whether the use of one of these Probiotics in hospitalised patients taking antibiotics will result in less diarrhoea, less Clostridium difficile infection, as well as cost saving. The study will also analyze the effects of probiotics on quality of life and length of hospital stay.

Detailed description

As part of this study, we will look at both microbiological and immunological markers, in addition to analyzing the overall cost implications by analysis of health economics.

Conditions

• Diarrhoea
• Clostridium Difficile

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic drink containing the live strain	Probiotic drink contains no strain
DIETARY_SUPPLEMENT	placebo probiotic	Placebo product is a sweetened flavoured, non fermented, acidified dairy drink

Timeline

• Start date: 2009-10-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2010-03-16
• Last updated: 2020-03-30

Locations

26 sites across 1 country: United Kingdom