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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

231 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-12-31

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.

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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.

Conditions

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Diarrhoea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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VSL#3

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

Group Type ACTIVE_COMPARATOR

VSL#3

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Bifidobacterium breve Bifidobacterium longum Bifidobacterium infantis Lactobacillus acidophilus Lactobacillus plantarum Lactobacillus paracasei Lactobacillus bulgaricus Streptococcus thermophilus Maltose based Placebo

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No