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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diarrhoea

Intervention / Treatment
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* Drug: VSL#3
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: VSL#3<br>Patients will receive one VSL #3 sachets twice a day for the duration of the antibiotic course and for one week after. | Drug: VSL#3<br>* Patients will o receive one VSL #3 sachets twice a day for the duration of the antibiotic course and for one week after.<br>* Other names: Streptococcus thermophilus;|
| Placebo Comparator: Placebo<br>Patients will one placebo sachet twice a day for the duration of the antibiotic course and for one week after. | Drug: Placebo<br>* Patients will one placebo sachet twice a day for the duration of the antibiotic course and for one week after.<br>* Other names: Maltose based Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of antibiotic associated diarrhoea |  | 28 days post last antibiotic dose | 
| Development of Clostridium difficile associated diarrhoea |  | 28 days post last antibiotic dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Hospital Stay |  | 28 days post last antibiotic dose | 
| 30-day Mortality |  | 30 days after initiation of therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clostridium difficile associated diarrhoea, antibiotic associated diarrhoea