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Trial registered on ANZCTR
Registration number
ACTRN12610000932066
Ethics application status
Approved
Date submitted
1/11/2010
Date registered
3/11/2010
Date last updated
3/11/2010
Type of registration
Retrospectively registered
Titles & IDs
Public title
A study to assess the efficacy of a probiotic in the restoration of bowel function of patients undergoing reversal of ileostomy.
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Scientific title
A study to assess the efficacy of VSL#3 in the restoration of bowel function of patients undergoing reversal of ileostomy.
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Secondary ID [1]
252995
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Reversal of temporary loop ileostomy
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Condition category
Condition code
Oral and Gastrointestinal
258691
258691
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Alternative and Complementary Medicine
258700
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0
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Other alternative and complementary medicine
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
VSL#3
Dosage: 2.5g sachet twice daily for 4 weeks
Ingredients: 450 billion lactic acid bacteria, cornstarch
Mode: orally mixed with water or apple juice
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Intervention code [1]
257516
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Treatment: Other
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Comparator / control treatment
Placebo
Dosage: 2.5g sachet twice daily for 4 weeks
Ingredients: cornstarch
Mode: orally mixed with water or apple juice
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Control group
Placebo
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Outcomes
Primary outcome [1]
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To assess the efficacy of VSL#3 in improving the GastroIntestinal Quality of Life Index in patients who have undergone reversal of a loop ileostomy.
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Assessment method [1]
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Timepoint [1]
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GIQLI assessments weekly for the 4-week study period.
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Secondary outcome [1]
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The Bowel Function Diary will include recording frequency of bowel actions, abdominal pain, episodes of nausea and vomiting, incontinence episodes, and probiotic compliance.
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Assessment method [1]
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Timepoint [1]
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Bowel diary completed daily during the 4-week study period.
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Eligibility
Key inclusion criteria
1. Over 18 years of age
2. Able to fill in questionnaires and diary
3. Had an anterior resection or Hartmann's procedure
4. Undergoing reversal of ileostomy
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients with Coeliac Disease
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
2/03/2005
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
40
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
The Queen Elizabeth Hospital
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Address
Division of Surgery
28 Woodville Road
Woodville South
SA 5011
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
257171
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Country [1]
257171
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Orphan Australia Pty Ltd
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Address [1]
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300 Frankston-Dandenong Road
Dandenong
Victoria 3175
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Country [1]
251631
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Australia
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Ethics approval
Ethics application status
Approved
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Summary
Brief summary
Patients experience a period of altered bowel function after the reversal of a temporary loop ileostomy. This study aimed to assess whether a probiotic preparation, VSL#3, improved bowel function during the first month after loop ileostomy reversal.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
31855
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Address
31855
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Country
31855
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Phone
31855
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Fax
31855
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Email
31855
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Contact person for public queries
Name
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Prof Peter Hewett
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Address
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Division of Surgery
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South
SA 5011
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Country
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Australia
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Phone
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+61 8 8222 6000
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Prof Peter Hewett
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Address
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Division of Surgery
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South
SA 5011
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Country
6030
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Australia
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Phone
6030
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+61 8 8222 6000
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Fax
6030
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Email
6030
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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