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ISRCTN
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ISRCTN72387688
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ClinicalTrials.gov identifier
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Public title
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Probiotic VSL#3 as a treatment for food intolerant irritable bowel syndrome (IBS)
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0544129304
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Study hypothesis
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Probiotic VSL#3 as a treatment for food intolerant irritable bowel syndrome.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Irritable bowel syndrome (IBS)
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Participants - inclusion criteria
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20 subjects aged 18 - 65 years, either sex
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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28/03/2003
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Anticipated end date
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27/03/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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20
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Interventions
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Patients with suspected food intolerant IBS will be randomised to receive either VSL#3, a probiotic containing 8 non-pathogenic strains of bacteria or a placebo. The dose of either the VSL#3 or the placebo is dependent on the number of daily bowel movements. The patient will be required to take the full dose of VSL#3 or placebo for 6 weeks. A validated symptom score will used to record symptoms for 2 weeks prior to starting the treatment and for two weeks after one month has elapsed. The validated symptom score will be used to assess if any statistical improvement has occurred in their symptoms. The study will be double-blinded.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Cambridge Consortium - Addenbrooke's (UK)
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Trial website
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Publications
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Contact name
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Prof
John O
Hunter
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Address
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Box No 262
Dept of Gastroenterology
Addenbrooke's NHS Trust
Hills Road
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City/town
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Cambridge
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Zip/Postcode
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CB2 2QQ
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Country
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United Kingdom
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Tel
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+44 (0)1223 217469
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Fax
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+44 (0)1223 211443
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Email
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john.hunter@addenbrookes.nhs.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
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Address
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The Department of Health,
Richmond House,
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2004
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Last edited
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15/11/2011
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Date ISRCTN assigned
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30/09/2004
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