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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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.
Scientific title
A study to assess the efficacy of VSL#3 in the restoration of bowel function of patients undergoing reversal of ileostomy.
Secondary ID [1] 252995 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Reversal of temporary loop ileostomy 258544 0
Condition category
Condition code
Oral and Gastrointestinal 258691 258691 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Alternative and Complementary Medicine 258700 258700 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 257516 0
Treatment: Other
Comparator / control treatment
Placebo

Dosage: 2.5g sachet twice daily for 4 weeks
Ingredients: cornstarch
Mode: orally mixed with water or apple juice
Control group
Placebo

Outcomes
Primary outcome [1] 259549 0
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.
Timepoint [1] 259549 0
GIQLI assessments weekly for the 4-week study period.
Secondary outcome [1] 266169 0
The Bowel Function Diary will include recording frequency of bowel actions, abdominal pain, episodes of nausea and vomiting, incontinence episodes, and probiotic compliance.
Timepoint [1] 266169 0
Bowel diary completed daily during the 4-week study period.

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with Coeliac Disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257976 0
Self funded/Unfunded
Name [1] 257976 0
Address [1] 257976 0
Country [1] 257976 0
Australia
Primary sponsor type
Hospital
Name
The Queen Elizabeth Hospital
Address
Division of Surgery
28 Woodville Road
Woodville South
SA 5011
Country
Australia
Secondary sponsor category [1] 257171 0
None
Name [1] 257171 0
Address [1] 257171 0
Country [1] 257171 0
Other collaborator category [1] 251631 0
Commercial sector/Industry
Name [1] 251631 0
Orphan Australia Pty Ltd
Address [1] 251631 0
300 Frankston-Dandenong Road
Dandenong
Victoria 3175
Country [1] 251631 0
Australia

Ethics approval
Ethics application status
Approved

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31855 0
Address 31855 0
Country 31855 0
Phone 31855 0
Fax 31855 0
Email 31855 0
Contact person for public queries
Name 15102 0
Prof Peter Hewett
Address 15102 0
Division of Surgery
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South
SA 5011
Country 15102 0
Australia
Phone 15102 0
+61 8 8222 6000
Fax 15102 0
Email 15102 0
peter.hewett@health.sa.gov.au
Contact person for scientific queries
Name 6030 0
Prof Peter Hewett
Address 6030 0
Division of Surgery
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South
SA 5011
Country 6030 0
Australia
Phone 6030 0
+61 8 8222 6000
Fax 6030 0
Email 6030 0
peter.hewett@health.sa.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary