Clinical trial NCT00973908: Probiotics for the Prevention of Antibiotics Associated Diarrhoea and Clostridium Difficile Associated Diarrhoea
Official title: Probiotics for the Prevention of Antibiotics Associated Diarrhoea and Clostridium Difficile Associated Diarrhoea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Diarrhoea
Keywords: Clostridium difficile associated diarrhoea
antibiotic associated diarrhoea
Lead sponsor: National Health Service, United Kingdom
Sponsor class: OTHER_GOV
Collaborators: name: Wrightington, Wigan and Leigh NHS Foundation Trust
name: Ferring Pharmaceuticals
name: South London and Maudsley NHS Foundation Trust
name: North Bristol NHS Trust
name: Hull University Teaching Hospitals NHS Trust
First posted: 2009-09-09
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators aim to investigate whether the routine use of the probiotic formulation VSL#3 co-prescribed with antibiotics reduces the incidence of both Antibiotic associated diarrhoea and Clostridium Difficile associated diarrhoea.

Detailed description: The investigators aim to find out whether VSL#3 can prevent Antibiotic associated diarrhoea and Clostridium Difficile associated diarrhoea when VSL#3 is giving during a course of systemic antibiotics. Patients will be randomized in a 1:1 proportion to receive either one sachet of VSL#3 or a similar looking placebo twice a day. This will be given for the length of the antibiotic course and another week thereafter. Follow-up will last until 28 days after the last antibiotic dose. Patient restarted on antibiotics during follow-up will be restarted on the trial medication and the 28 day follow-up will be recommenced.

This trial has 2 co-primary outcome measures.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18 or older
* Hospital inpatients
* On systemic antibiotics for an infection
* Antibiotics started within last 48 hours

Exclusion Criteria:

* Diarrhoea at screening
* Unable to take enteral meds
* Patients on intensive care units
* Severe Immunosuppression (neutropenia, AIDS, congenital immunoparesis, chemotherapy)
* Risk of endocarditis (Artificial heart valves, history of rheumatic heart disease or infective endocarditis)
* Regular consumption of probiotics until 1 week prior to admission
* Acute severe pancreatitis Persistent vomiting (two days or more)

Primary outcomes:
measure: Development of antibiotic associated diarrhoea
timeFrame: 28 days post last antibiotic dose
measure: Development of Clostridium difficile associated diarrhoea
timeFrame: 28 days post last antibiotic dose
Secondary outcomes:
measure: Length of Hospital Stay
timeFrame: 28 days post last antibiotic dose
measure: 30-day Mortality
timeFrame: 30 days after initiation of therapy
Other outcomes:
Locations:
city: Wigan
country: United Kingdom
facility: Royal Albert Edward Infirmary
state: Lancashire
city: Woolwich
country: United Kingdom
facility: Queen Elizabeth Hospital
state: London
city: Bristol
country: United Kingdom
facility: Frenchay Hospital
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary
city: Weston-super-Mare
country: United Kingdom
facility: Weston General Hospital
Study officials:
affiliation: Wirghtington Wigan and Leigh NHS Trust
name: Neil Haslam
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bergogne-Berezin E. Treatment and prevention of antibiotic associated diarrhea. Int J Antimicrob Agents. 2000 Dec;16(4):521-6. doi: 10.1016/s0924-8579(00)00293-4.
citation: D'Souza AL, Rajkumar C, Cooke J, Bulpitt CJ. Probiotics in prevention of antibiotic associated diarrhoea: meta-analysis. BMJ. 2002 Jun 8;324(7350):1361. doi: 10.1136/bmj.324.7350.1361.
citation: Cremonini F, Di Caro S, Nista EC, Bartolozzi F, Capelli G, Gasbarrini G, Gasbarrini A. Meta-analysis: the effect of probiotic administration on antibiotic-associated diarrhoea. Aliment Pharmacol Ther. 2002 Aug;16(8):1461-7. doi: 10.1046/j.1365-2036.2002.01318.x.
citation: Selinger CP, Bell A, Cairns A, Lockett M, Sebastian S, Haslam N. Probiotic VSL#3 prevents antibiotic-associated diarrhoea in a double-blind, randomized, placebo-controlled clinical trial. J Hosp Infect. 2013 Jun;84(2):159-65. doi: 10.1016/j.jhin.2013.02.019. Epub 2013 Apr 22.