Probiotics for the Prevention of Antibiotics Associated Diarrhoea and Clostridium Difficile Associated Diarrhoea

Diarrhoea Clinical Trial

Official title:

Probiotics for the Prevention of Antibiotics Associated Diarrhoea and Clostridium Difficile Associated Diarrhoea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00973908
• Other study ID #: WWL - CDiff Prevention
• Secondary ID: EUDRACT 2008-005
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 8, 2009
• Last updated: April 25, 2013
• Start date: April 2010
• Est. completion date: December 2012

Study information

• Verified date: April 2013
• Source: National Health Service, United Kingdom
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: December 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diarrhea
• Diarrhoea

Intervention

Drug:
• VSL#3
Patients will o receive one VSL #3 sachets twice a day for the duration of the antibiotic course and for one week after.
• Placebo
Patients will one placebo sachet twice a day for the duration of the antibiotic course and for one week after.

Locations

Country	Name	City	State
United Kingdom	Frenchay Hospital	Bristol
United Kingdom	Hull Royal Infirmary	Hull
United Kingdom	Weston General Hospital	Weston-super-Mare
United Kingdom	Royal Albert Edward Infirmary	Wigan	Lancashire
United Kingdom	Queen Elizabeth Hospital	Woolwich	London

Sponsors (6)

Lead Sponsor	Collaborator
National Health Service, United Kingdom	Ferring Pharmaceuticals, Hull and East Yorkshire Hospitals NHS Trust, North Bristol NHS Trust, South London and Maudsley NHS Foundation Trust, Wrightington, Wigan and Leigh NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

Bergogne-Bérézin E. Treatment and prevention of antibiotic associated diarrhea. Int J Antimicrob Agents. 2000 Dec;16(4):521-6. Review. — View 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. Review. — View 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. Review. — View 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.2013.02.0 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of antibiotic associated diarrhoea		28 days post last antibiotic dose	No
Primary	Development of Clostridium difficile associated diarrhoea		28 days post last antibiotic dose	No
Secondary	Length of Hospital Stay		28 days post last antibiotic dose	No
Secondary	30-day Mortality		30 days after initiation of therapy	Yes