Clinical trial NCT01087892: Probiotics in Preventing Antibiotic Associated Diarrhoea Including Clostridium Difficile Infection
Official title: Probiotics in Preventing Antibiotic Associated Diarrhoea Including Clostridium Difficile Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diarrhoea
Clostridium Difficile
Lead sponsor: University of Sussex
Sponsor class: OTHER
Collaborators: name: Danone Institute International
First posted: 2010-03-16
Enrollment: 1126
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Male/female patients, above 55 years of age Patient has given written informed consent/Assent to take part in the study Patients are receiving antibiotics as inpatients Patients prescribed therapy with single or multiple antibiotics (oral or IV) will be included Antibiotic therapy must be indicated for a minimum of 72 hours Patients must be able to take medication orally Inclusion in the study is approved by the admitting consultant and validated by a member of the trial team within 48 hours

Exclusion Criteria:

* Age less than 55 years Pregnancy Patients on PEG feed. Diarrhoea on admission or within the preceding week Severe life-threatening illness

Subjects with allergy or hypersensitivity to any component of the study product (e.g.: allergy or hypersensitivity to milk proteins) Subjects who had any surgery or intervention in the last 4 weeks Subjects enrolled in another clinical study in the last 4 weeks Subjects who are thought not to comply with the clinical study Subjects presenting with a severe evolving or active pathology or infection of the gastrointestinal tract such as inflammatory bowel disease, Crohn's disease or ulcerative colitis, diverticular disease or liver cirrhosis.

Any condition affecting the pancreas including acute and chronic pancreatitis Patients who had a surgical operation in their bowels in the preceding 3 months A medical condition such that the life expectancy of the patient is predicted at less than 3 months by the admitting consultant and validated by a member of the trial team Immune-suppressed patients (e.g. HIV) Steroid use of Prednisolone greater than 10mg a day (or equivalent of Dexamethasone) for over 2 weeks prior to entering the trial Patients on Cytotoxic drugs Post-transplant patients Any clinical condition affecting the pancreas including acute and chronic pancreatitis Patients with prosthetic heart valves or a history of endocarditis. Patients who have taken probiotic drinks containing live organisms or over the counter probiotic preparations in the past seven days (see Appendix 10) Foreign travel in the last 7 days

Primary outcomes:
measure: The incidence of diarrhoea
timeFrame: regular intervals for 28days from entry to trial
Secondary outcomes:
measure: incidence and duration of Clostridium difficile toxin
timeFrame: regular intervals for 28 days from entry to trial
measure: The rate of recurrence of antibiotic associated diarrhoea in the active and placebo groups to the end of the follow up period
timeFrame: regular intervals for 28 days from entry to trial
measure: rate of recurrence of Clostridium difficile toxin positive diarrhoea
timeFrame: regular intervals for 28 days from entry to trial
measure: The quality of life in the active and placebo groups at enrollment into the study
timeFrame: regular intervals for 28 days from entry to trial
measure: 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
timeFrame: regular intervals for 28 days from entry to trial
Other outcomes:
Locations:
city: Ashford
country: United Kingdom
facility: Ashford and St Peters Hospital
city: Blackpool
country: United Kingdom
facility: Blackpool Vicotria Hospital
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospital Trust
city: Chelmsford
country: United Kingdom
facility: Broomfield Hospital
city: Chichester
country: United Kingdom
facility: St.Richards Hospital
city: Colchester
country: United Kingdom
facility: Colchester Hospitals University
city: Ealing
country: United Kingdom
facility: Ealing Hospital
city: Eastbourne
country: United Kingdom
facility: Eastbourne District General Hospital
city: Frimley
country: United Kingdom
facility: Frimley Park Hospital
city: Haywards Heath
country: United Kingdom
facility: Princess Royal Hospital
city: Hillingdon
country: United Kingdom
facility: Hillingdon Hospital
city: Lancaster
country: United Kingdom
facility: Lancashire Teaching Hospital
city: Leicester
country: United Kingdom
facility: University Hosppitals of Leicester
city: Lewisham
country: United Kingdom
facility: Lewisham Helathcare NHS Trust
city: London
country: United Kingdom
facility: Kings College Hospital
city: London
country: United Kingdom
facility: St Georges Hospital London
city: Margate
country: United Kingdom
facility: Queen Elizabeth Queen Mother Hospital
city: Morecambe
country: United Kingdom
facility: University Hospitals of Morecambe Bay
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals NHS Trust
city: Redditch
country: United Kingdom
facility: Worcestershire Acute Hospitals
city: Redhill
country: United Kingdom
facility: East Surrey Hospital
city: Southampton
country: United Kingdom
facility: University Hospital Southampton
city: Tunbridge Wells
country: United Kingdom
facility: Maidstone and Tunbridge Wells NHS Trust
city: Yeovil
country: United Kingdom
facility: Yeovil District Hospital
Study officials:
affiliation: University of Sussex
name: Chakravarthi Rajkumar
role: STUDY_CHAIR
References: