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DiarrhoeaPhase 2/3NCT00973908

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

A Phase 2/3 study testing VSL#3 in people with Diarrhoea, run by National Health Service, United Kingdom at 5 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diarrhoea
What is being tested?
VSL#3
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
231 participants
Where
5 sitesUnited Kingdom
Study dates
Apr 2010to Dec 2012
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults aged 18 or older
  • Hospital inpatients
  • On systemic antibiotics for an infection
  • Antibiotics started within last 48 hours

Who cannot join

  • 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 locations and contacts

5 sites in 1 country.

5 sites in 1 country

United Kingdom5 sites

  • Frenchay Hospital

    Bristol, BS16 1LE

  • Hull Royal Infirmary

    Hull, HU3 2JZ

  • Weston General Hospital

    Weston-super-Mare, BS23 4TQ

  • Royal Albert Edward Infirmary

    Wigan, Lancashire, WN1 2NN

  • Queen Elizabeth Hospital

    Woolwich, London, SE18 4QH

Other trials in United Kingdom

About this study

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.

Read the detailed 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.

Conditions
Diarrhoea
Being tested
VSL#3, Placebo
Keywords
Clostridium difficile associated diarrhoea, antibiotic associated diarrhoea
Medical subject headings
Diarrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VSL#3Drug

    Also called Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis, Lactobacillus acidophilus

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

  • PlaceboDrug

    Also called Maltose based Placebo

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

Study groups in NCT00973908
Study groupRoleWhat they receive
VSL#3Active comparatorPatients will receive one VSL #3 sachets twice a day for the duration of the antibiotic course and for one week after.
Receives: Drug: VSL#3
PlaceboPlacebo comparatorPatients will one placebo sachet twice a day for the duration of the antibiotic course and for one week after.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Development of antibiotic associated diarrhoea

    Measured: 28 days post last antibiotic dose

  2. Development of Clostridium difficile associated diarrhoea

    Measured: 28 days post last antibiotic dose

Secondary outcomes (2)

  1. Length of Hospital Stay

    Measured: 28 days post last antibiotic dose

  2. 30-day Mortality

    Measured: 30 days after initiation of therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2009 (estimated)
  2. Study startApr 2010
  3. Primary completionApr 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
231 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00973908
Sponsor's protocol ID
WWL - CDiff Prevention
Other IDs
EUDRACT 2008-005244-16
Status last verified
Apr 2013
First submitted
8 Sep 2009
Last updated
26 Apr 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Bergogne-Berezin E. Treatment and prevention of antibiotic associated diarrhea. Int J Antimicrob Agents. 2000 Dec;16(4):521-6. doi: 10.1016/s0924-8579(00)00293-4.

    PubMed 11118872

  • 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. doi: 10.1136/bmj.324.7350.1361.

    PubMed 12052801

  • 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. doi: 10.1046/j.1365-2036.2002.01318.x.

    PubMed 12182746

  • 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.2013.02.019. Epub 2013 Apr 22.

    PubMed 23618760

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing VSL#3 in people with Diarrhoea, run by National Health Service, United Kingdom at 5 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Development of antibiotic associated diarrhoea (time frame: 28 days post last antibiotic dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00973908, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2013.

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