Probiotics in Preventing Antibiotic Associated Diarrhoea Including Clostridium Difficile Infection
- Conditions
- Clostridium DifficileDiarrhoea
- Interventions
- Dietary Supplement: Probiotic drink containing the live strainDietary Supplement: placebo probiotic
- Registration Number
- NCT01087892
- Lead Sponsor
- University of Sussex
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1126
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dietary supplement Probiotic drink Probiotic drink containing the live strain Double blind Probiotic containing the live strain 100g/day orally, twice daily for the duration of the course of antibiotics plus seven days Dietary supplement probiotic placebo drink placebo probiotic Double blind 'placebo' is actually a control product Placebo drink contains no strain 100gs orally, twice daily for the duration of the course of antibiotics plus seven days
- Primary Outcome Measures
Name Time Method The incidence of diarrhoea regular intervals for 28days from entry to trial The incidence of antibiotic associated diarrhoea in the active and placebo group by the end of the follow up period
- Secondary Outcome Measures
Name Time Method incidence and duration of Clostridium difficile toxin regular intervals for 28 days from entry to trial 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
The rate of recurrence of antibiotic associated diarrhoea in the active and placebo groups to the end of the follow up period 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
rate of recurrence of Clostridium difficile toxin positive diarrhoea regular intervals for 28 days from entry to trial 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
The quality of life in the active and placebo groups at enrollment into the study 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 regular intervals for 28 days from entry to trial
Trial Locations
- Locations (26)
Blackpool Vicotria Hospital
🇬🇧Blackpool, United Kingdom
Cambridge University Hospital Trust
🇬🇧Cambridge, United Kingdom
Ealing Hospital
🇬🇧Ealing, United Kingdom
Eastbourne District General Hospital
🇬🇧Eastbourne, United Kingdom
Hillingdon Hospital
🇬🇧Hillingdon, United Kingdom
Lancashire Teaching Hospital
🇬🇧Lancaster, United Kingdom
University Hosppitals of Leicester
🇬🇧Leicester, United Kingdom
Lewisham Helathcare NHS Trust
🇬🇧Lewisham, United Kingdom
St Georges Hospital London
🇬🇧London, United Kingdom
Queen Elizabeth Queen Mother Hospital
🇬🇧Margate, United Kingdom
Kings College Hospital
🇬🇧London, United Kingdom
Ashford and St Peters Hospital
🇬🇧Ashford, United Kingdom
Royal Sussex County Hospital
🇬🇧Brighton, United Kingdom
Broomfield Hospital
🇬🇧Chelmsford, United Kingdom
St.Richards Hospital
🇬🇧Chichester, United Kingdom
Colchester Hospitals University
🇬🇧Colchester, United Kingdom
Frimley Park Hospital
🇬🇧Frimley, United Kingdom
Princess Royal Hospital
🇬🇧Haywards Heath, United Kingdom
Yeovil District Hospital
🇬🇧Yeovil, United Kingdom
Norfolk and Norwich University
🇬🇧Norwich, United Kingdom
University Hospitals of Morecambe Bay
🇬🇧Morecambe, United Kingdom
Portsmouth Hospitals NHS Trust
🇬🇧Portsmouth, United Kingdom
Worcestershire Acute Hospitals
🇬🇧Redditch, United Kingdom
East Surrey Hospital
🇬🇧Redhill, United Kingdom
University Hospital Southampton
🇬🇧Southampton, United Kingdom
Maidstone and Tunbridge Wells NHS Trust
🇬🇧Tunbridge Wells, United Kingdom