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

National Health Service, United Kingdom

Status and phase: Completed; Phase 3; Phase 2

Conditions: Diarrhoea

Treatments: Drug: Placebo; Drug: VSL#3

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00973908

EUDRACT 2008-005244-16

WWL - CDiff Prevention

Details and patient eligibility

About

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.

Full 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.

Enrollment: 231 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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231 participants in 2 patient groups, including a placebo group

VSL#3

Active Comparator group

Description:

Patients will receive one VSL #3 sachets twice a day for the duration of the antibiotic course and for one week after.

Treatment:

Drug: VSL#3

Placebo

Placebo Comparator group

Description:

Patients will one placebo sachet twice a day for the duration of the antibiotic course and for one week after.

Treatment:

Drug: Placebo