Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000544774
Ethics application status
Not yet submitted
Date submitted
10/05/2013
Date registered
15/05/2013
Date last updated
15/05/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Probiotic dietary supplement and stool evaluation to improve ileal pouch health
Scientific title
Patients with an ileal pouch for ulcerative colitis taking a probiotic for 8 weeks as an open label phase one study to assess its effect on pouch function, quality of life, and to evaluate any alteration in stool microbiota.
Secondary ID [1] 282484 0
Nil
Universal Trial Number (UTN)
U1111-1142-8913
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pouchitis 289117 0
Ulcerative colitis 289144 0
Condition category
Condition code
Oral and Gastrointestinal 289453 289453 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A freeze dried probiotic powder taken in one gelatin capsule taken twice a day for 8 weeks. Each capsule will contain 10^9 colony-forming units of (bacterium name) per capsule.

To monitor compliance at the end of 8 weeks all participants will be asked to return the dispensing container with any unused capsules.
Intervention code [1] 287133 0
Treatment: Other
Comparator / control treatment
No control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289557 0
Clinical measure of pouch function using clinical portion of the Pouchitis Disease Activity Index.
Timepoint [1] 289557 0
after 8 weeks of probiotic
Secondary outcome [1] 302739 0
Quality of life using Short Form 12.
Timepoint [1] 302739 0
After 8 weeks of probiotic.
Secondary outcome [2] 302740 0
Presence of probiotic in stool
Timepoint [2] 302740 0
weeks 0, 1, 2, 4, 8, and 3 weeks post treatment
Secondary outcome [3] 302741 0
DNA profile of selected bacteria
Timepoint [3] 302741 0
weeks 0, 1, 2, 4, 8, and 3 weeks post treatment
Secondary outcome [4] 302742 0
Faecal calprotectin
Timepoint [4] 302742 0
weeks 0, 1, 2, 4, 8, and 3 weeks post treatment

Eligibility
Key inclusion criteria
Functioning ileal J pouch for ulcerative colitis
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
unable to provide informed consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2013
Actual
Date of last participant enrolment
Anticipated
29/11/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 5075 0
New Zealand
State/province [1] 5075 0

Funding & Sponsors
Funding source category [1] 287264 0
Hospital
Name [1] 287264 0
Colorectal Trust Fund
Dunedin Public Hospital
Country [1] 287264 0
New Zealand
Funding source category [2] 287265 0
University
Name [2] 287265 0
Otago Innovation Ltd
University of Otago
Country [2] 287265 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Department of Surgical Sciences
Private Bag 56
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 286018 0
Hospital
Name [1] 286018 0
Dunedin Public Hospital
Address [1] 286018 0
Department of Surgery
Great King Street
Dunedin 9054
Country [1] 286018 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289244 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 289244 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 6145
Ethics committee country [1] 289244 0
New Zealand
Date submitted for ethics approval [1] 289244 0
21/06/2013
Approval date [1] 289244 0
Ethics approval number [1] 289244 0

Summary
Brief summary
An ileal pouch is formed when the end of the small bowel is used to create a pouch and anastomosed to the anus.
This is required in patients who need removal of all their colon and rectum, most commonly for ulcerative colitis.
The ileal pouch mucosa (or lining) exists in a state of a varying degree of chronic inflammation. When this is more
severe clinical pouchitis develops. Pouchitis is most likely due to an alteration in the microbiota that the ileal
mucosa is exposed to. The microbiota alter due to increased stasis of the contents of the ileal pouch, compared to
ileum in the normal state. From our previous research and that of others, certain bacteria are associated with less
inflammation and certain with more inflammation. We have selected a bacterial culture from previous research that
is associated with a healthy pouch. We have been able to develop this bacterium into a probiotic. We wish to use
this probiotic as a dietary supplement to see if we can improve the health, function and quality of life in ileal pouch
patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39942 0
A/Prof Mark Thompson-Fawcett
Address 39942 0
Department of Surgical Sciences
University of Otago
Private Bag 56
Dunedin 9054
Country 39942 0
New Zealand
Phone 39942 0
+64 3 4740999
Fax 39942 0
+64 3 4709677
Email 39942 0
[email protected]
Contact person for public queries
Name 39943 0
Ms Lesley Reeves
Address 39943 0
Department of Surgical Sciences
University of Otago
Private Bag 56
Dunedin 9054
Country 39943 0
New Zealand
Phone 39943 0
+64 3 4740999 ext 8847
Fax 39943 0
+64 3 4709677
Email 39943 0
[email protected]
Contact person for scientific queries
Name 39944 0
A/Prof Mark Thompson-Fawcett
Address 39944 0
Department of Surgical Sciences
University of Otago
Private Bag 56
Dunedin 9054
Country 39944 0
New Zealand
Phone 39944 0
+64 3 4740999
Fax 39944 0
+64 3 4709677
Email 39944 0
[email protected]

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
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Documents added automatically
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