Clostridium difficile associated diarrhoea Digestive System Diarrhoea
Conditions
Interventions
Adjuvant VSL#3® (probiotic) or placebo, two sachets three times per day, one hour prior to antibiotic therapy.
Total duration of treatment is dependent on the length of symptoms. These usually range
Sponsors
University Hospitals Bristol NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Any consenting adult patient over the age of 18 years admitted to a Clostridium difficile Cohort Ward in either Gloucester Royal Hospital or Cheltenham General Hospital. Male and female genders will be included.
Exclusion criteria
Exclusion criteria: There is no upper age limit and patients with IBD will not be excluded. Apart from this, the following patients will be excluded: 1. Those with evidence of dilated colon on plain abdominal film on admission 2. Any patient known to be immunosuppressed (including those on steroids) 3. Any patient refusing the VSL#3® as part of their treatment regime 4. Patients with lactose intolerance or allergy 5. Any patient with a history of rheumatic heart disease or prosthetic heart valve 6. Any patient with a history of endocarditis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Reduction in length of symptoms by 20%, approx expectation is 7 - 10 days 2. Reduction in rates of recurrence of Clostridium difficile associated diarrhoea (CDAD) by 50%, measured within 4 weeks of resolution of symptoms | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Reduction in mortality due to primary endpoints mentioned above, measured from admission to one month post resolution of symptoms 2. Reduction in incidence of colitis (colitis diagnosed by abdominal x-ray or computed tomography [CT] and serological markers +/- sigmoidoscopy) | — |
Countries
United Kingdom
Outcome results
None listed