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ISRCTN
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ISRCTN45167712
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ClinicalTrials.gov identifier
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Public title
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The effect of oral administration of a multispecies probiotic product in healthy volunteers and ileostomy patients; double-blind, placebo-controlled, cross-over trial
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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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04-088
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Study hypothesis
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Ecologic 641 (a multispecies probiotic) is well tolerated and is capable of modifying gut flora.
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Lay summary
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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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Netherlands
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Disease/condition/study domain
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Healthy volunteers and ileostomy patients after ulcerative colitis
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Participants - inclusion criteria
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10 healthy volunteers and 10 ileostomy patients after ulcerative colitis
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Participants - exclusion criteria
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Use of antibiotics and/or probiotics within 2 weeks prior to randomisation
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Anticipated start date
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01/08/2004
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Anticipated end date
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01/07/2005
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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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Administration of probiotics or placebo
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Primary outcome measure(s)
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Tolerance of study product and gut flora modification
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Secondary outcome measure(s)
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Side effects, discomfort scores (visual analogue scale [VAS] scale)
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Sources of funding
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Senter, an agency of the Dutch Ministry of Economic Affairs, funded this study (grant number: TSGE3109) (Netherlands)
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Trial website
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Publications
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Contact name
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Prof
Louis MA
Akkermans
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Address
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Heidelberglaan 100
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City/town
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Utrecht
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Zip/Postcode
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3584 CX
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Country
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Netherlands
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Tel
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+31 30 2508074
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Fax
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+31 30 2541944
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Email
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l.m.a.akkermans@umcutrecht.nl
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Sponsor
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Individual Sponsor (Netherlands)
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Address
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Prof Louis MA Akkermans
Heidelberglaan 100
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City/town
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Utrecht
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Zip/Postcode
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3584CX
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Country
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Netherlands
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Tel
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+31 30 2508074
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Fax
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+31 30 2541944
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Email
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l.m.a.akkermans@umcutrecht.nl
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Sponsor website:
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http://www.prosearch.nl
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Date applied
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28/06/2005
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Last edited
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14/09/2009
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Date ISRCTN assigned
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12/09/2005
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