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Completed

NCT Number: NCT00973908

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

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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Key information

Conditions

Diarrhoea Diarrhea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Royal Albert Edward Infirmary, Wigan, Lancashire, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

VSL#3

Drug

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

Other names: Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus paracasei, Lactobacillus bulgaricus, Streptococcus thermophilus

Placebo

Drug

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

Other names: Maltose based Placebo

Primary outcomes

  1. Development of antibiotic associated diarrhoea

    Time frame: 28 days post last antibiotic dose

  2. Development of Clostridium difficile associated diarrhoea

    Time frame: 28 days post last antibiotic dose

Secondary outcomes

  1. Length of Hospital Stay

    Time frame: 28 days post last antibiotic dose

  2. 30-day Mortality

    Time frame: 30 days after initiation of therapy

Sponsors and collaborators

Lead sponsor

National Health Service, United Kingdom

Other Gov

Collaborators

  • Ferring Pharmaceuticals
  • Hull University Teaching Hospitals NHS Trust
  • North Bristol NHS Trust
  • South London and Maudsley NHS Foundation Trust
  • Wrightington, Wigan and Leigh NHS Foundation Trust

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Sep 9, 2009
Registry last updated
Apr 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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