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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,126
Probiotic drink contains no strain
Placebo product is a sweetened flavoured, non fermented, acidified dairy drink
Ashford and St Peters Hospital
Ashford, United Kingdom
Blackpool Vicotria Hospital
Blackpool, United Kingdom
Royal Sussex County Hospital
Brighton, United Kingdom
Cambridge University Hospital Trust
Cambridge, United Kingdom
Broomfield Hospital
Chelmsford, United Kingdom
St.Richards Hospital
Chichester, United Kingdom
Colchester Hospitals University
Colchester, United Kingdom
Ealing Hospital
Ealing, United Kingdom
Eastbourne District General Hospital
Eastbourne, United Kingdom
Frimley Park Hospital
Frimley, United Kingdom
...and 16 more locations
The incidence of diarrhoea
The incidence of antibiotic associated diarrhoea in the active and placebo group by the end of the follow up period
Time frame: regular intervals for 28days from entry to trial
incidence and duration of Clostridium difficile toxin
The incidence and duration of Clostridium difficile toxin detected by ELISA positive testing from a stool sample taken at the onset of diarrhoea in the active and placebo groups
Time frame: regular intervals for 28 days from entry to trial
The rate of recurrence of antibiotic associated diarrhoea in the active and placebo groups to the end of the follow up period
The rate of recurrence of antibiotic associated diarrhoea in the active and placebo groups to the end of the follow up period
Time frame: regular intervals for 28 days from entry to trial
rate of recurrence of Clostridium difficile toxin positive diarrhoea
The rate of recurrence of Clostridium difficile toxin positive diarrhoea in the active and placebo groups from hospital discharge until the end of the follow-up period
Time frame: regular intervals for 28 days from entry to trial
The quality of life in the active and placebo groups at enrollment into the study
Time frame: regular intervals for 28 days from entry to trial
The length of hospital stay from enrollment into the study until the end of the follow up period in the active and placebo groups The cost-effectiveness as evidenced by health economic calculations
Time frame: regular intervals for 28 days from entry to trial
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