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Trial registered on ANZCTR


Registration number
ACTRN12619000895189p
Ethics application status
Not yet submitted
Date submitted
6/06/2019
Date registered
26/06/2019
Date last updated
26/06/2019
Date data sharing statement initially provided
26/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of a Probiotic To Improve Ileal Pouch Health: A Randomised Controlled Trial
Scientific title
The Effect of a Probiotic To Improve Ileal Pouch Health: A Randomised Controlled Trial
Secondary ID [1] 296929 0
None
Universal Trial Number (UTN)
U1111-1227-9814
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pouchitis following ileal pouch formation due to colorectal resection 312698 0
Ulcerative colitis 312699 0
Condition category
Condition code
Surgery 311200 311200 0 0
Other surgery
Oral and Gastrointestinal 311703 311703 0 0
Inflammatory bowel disease
Oral and Gastrointestinal 311704 311704 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment arm:
Participants will be asked to take one gelatine capsule with 10^9 CFU of the probiotic Bifidobacterium catentulatum morning and evening (two per day) for 8 weeks in their own homes. These will be provided fortnightly by a research coordinator. Adherence will be monitored with a diary recorded by the participant and monitored weekly.
Intervention code [1] 314373 0
Treatment: Other
Comparator / control treatment
Control arm:
Participants will be asked to take one gelatine capsule with 10^9 CFU of the probiotic Bifidobacterium catentulatum morning and evening (two per day) for 8 weeks in their own homes. These will be provided fortnightly by a research coordinator. Adherence will be monitored with a diary recorded by the participant and monitored weekly.
Control group
Placebo

Outcomes
Primary outcome [1] 319958 0
Faecal Calprotectin levels, as measured in participant stool samples. Faecal assays will be done by Southern Community labs, Christchurch, New Zealand, using the Philcal Calprotectin ELISA Kit from CALPRO AS, Lysaker, Norway
Timepoint [1] 319958 0
At baseline, after 8 weeks of treatment, and 4 weeks post-treatment.
Primary outcome [2] 319959 0
Participant quality of life, assessed using the Short-form 12 psychometric questionnaire. Initial questionnaires will be administered by the research assistant. The following two questionnaires will be mailed out to participants to fill in and return.
Timepoint [2] 319959 0
At baseline, after 8 weeks of treatment, and 4 weeks post-treatment.
Primary outcome [3] 319960 0
Pouch dysfunction score, as assessed using the “Pouch Dysfunction Score” questionnaire:
Brandsborg S, Nicholls RJ, Mortensen LS, Laurberg S. Restorative proctocolectomy for ulcerative colitis: development and validation of a new scoring system for pouch dysfunction and quality of life. Colorectal Dis. 2013;15(12):e719-25. The initial questionnaire will be administered by the research assistant, subsequent questionnaires will be mailed to participants to return.
Timepoint [3] 319960 0
At baseline, after 8 weeks of treatment, and 4 weeks post-treatment.
Secondary outcome [1] 369991 0
Number of colony forming units (CFU) in faecal samples. This will be measured using quantitative polymerase chain reaction (qPCR) analysis.
Timepoint [1] 369991 0
At baseline, 8 weeks after treatment, and 4 weeks post-treatment.
Secondary outcome [2] 371464 0
Type of colony forming units (CFU) in faecal samples. This will be measured using quantitative polymerase chain reaction (qPCR) analysis.
Timepoint [2] 371464 0
At baseline, 8 weeks after treatment, and 4 weeks post-treatment
Secondary outcome [3] 371846 0
Adverse events, assessed and recorded by patients or investigators. If study participants experience minor adverse effects on their gastrointestinal function coinciding with taking the probiotic, they will asked to notify the investigators. If the adverse effects are more than minor, such as illness requiring hospitalisation, then study participants will be asked to stop taking the supplement until after they have discussed this with the investigators.
Timepoint [3] 371846 0
at any stage during the trial.

Eligibility
Key inclusion criteria
1. Patients with an ileal J pouch for ulcerative colitis functioning for at least 3 months.
2. Living within the catchment of the five identified DHBs (Southern, Canterbury, Capital and Coast, Waikato and Auckland).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Age <18 years
2. Participant too unwell to answer questionnaires (for example is known to have dementia).

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)
Allocation will be undertaken using numbered containers, provided by a central administration site. These containers will be filled and numbered by a person who is not involved with recruitment or assessment in this study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (R Core Team (2018). R: A language and environment for statistical computing. R
Foundation for Statistical Computing, Vienna, Austria. URL
https://www.R-project.org/.)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Patient demographics will be described using appropriate descriptive statistics (mean and standard deviation for approximately normally distributed continuous variables, median and inter-quartile range for other continuous variables, count and percentage for categorical variables). Categorical variables will be compared using the chi-square test or Fisher’s exact test depending on frequency, and continuous variables, such as faecal calprotectin levels, will be compared using the Student’s t-test or the Mann-Whitney U test depending on the distribution of the data. Standard parametric statistical tests will be used to compare SF-12 and pouchitis data arising from the two treatment arms. Mean values and SD for each domain will be calculated and t-tests will be performed for the comparisons [Probiotic vs Placebo]. In addition, SF-12 domains will be compared using the non-parametric equivalent methods of Mann– Whitney U-tests for pairwise comparisons. Statistical significance will be set at p<0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/09/2019
Actual
Date of last participant enrolment
Anticipated
3/02/2020
Actual
Date of last data collection
Anticipated
30/04/2020
Actual
Sample size
Target
155
Accrual to date
Final
Recruitment outside Australia
Country [1] 21454 0
New Zealand
State/province [1] 21454 0
Auckland, Waikato, Wellington, Canterbury, Otago

Funding & Sponsors
Funding source category [1] 301503 0
Charities/Societies/Foundations
Name [1] 301503 0
Lottery Health Grant
Country [1] 301503 0
New Zealand
Funding source category [2] 302678 0
University
Name [2] 302678 0
University of Otago Research Grant
Country [2] 302678 0
New Zealand
Funding source category [3] 302679 0
Charities/Societies/Foundations
Name [3] 302679 0
Colorectal surgical society of Australia and New Zealand
Country [3] 302679 0
Australia
Primary sponsor type
University
Name
University of Otago
Address
362 Leith St, North Dunedin, Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 301200 0
Hospital
Name [1] 301200 0
Dunedin Hospital
Address [1] 301200 0
201 Great King St, Dunedin, 9016
Country [1] 301200 0
New Zealand
Other collaborator category [1] 280667 0
Hospital
Name [1] 280667 0
Christchurch Hospital
Address [1] 280667 0
2 Riccarton Ave, Christchurch Central, Christchurch 8011
Country [1] 280667 0
New Zealand
Other collaborator category [2] 280668 0
Hospital
Name [2] 280668 0
Auckland Hospital
Address [2] 280668 0
2 Park Rd, Grafton, Auckland 1023
Country [2] 280668 0
New Zealand
Other collaborator category [3] 280669 0
Hospital
Name [3] 280669 0
Waikato Hospital
Address [3] 280669 0
Pembroke Street, Hamilton West, Hamilton 3204
Country [3] 280669 0
New Zealand
Other collaborator category [4] 280670 0
Hospital
Name [4] 280670 0
Wellington Hospital
Address [4] 280670 0
23 Mein St, Newtown, Wellington 6021
Country [4] 280670 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 302245 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 302245 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 302245 0
New Zealand
Date submitted for ethics approval [1] 302245 0
28/06/2019
Approval date [1] 302245 0
Ethics approval number [1] 302245 0

Summary
Brief summary
Aim: To determine if the probiotic Bifidobacterium catentulatum reduces elevated calprotectin levels in patients with an ileal pouch for UC using a double-blinded, randomised, placebo-controlled trial.
At least 155 patients will be randomised into one of two groups. One of these groups will receive a gelatin capsule containing 10^9 probiotic bacteria, and the other group will receive an identical gelatin capsule containing a placebo. Randomisation will be computer generated, and the investigators, study coordinator, and patients will be blinded to the treatment group. Both groups will be asked to take a capsule morning and evening for eight weeks. Study participants will be given two weeks of capsules at baseline, then twice weekly until the end of the study. To monitor compliance, the study coordinator will ask each patient to record how many capsules they have taken each day. Missed doses and adverse events will be recorded. Faecal samples and study surveys will be collected at baseline, after 8 weeks of treatment, and 4 weeks post-treatment. These outcomes will be compared between groups to determine the efficacy of the probiotic treatment.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 89566 0
A/Prof Mark Thompson-Fawcett
Address 89566 0
University of Otago
Department of Surgical Sciences
Dunedin School of Medicine
PO Box 56
Dunedin 9054
Country 89566 0
New Zealand
Phone 89566 0
+64 3 470 9850
Fax 89566 0
Email 89566 0
[email protected]
Contact person for public queries
Name 89567 0
Kari Clifford
Address 89567 0
University of Otago
Department of Surgical Sciences
Dunedin School of Medicine
PO Box 56
Dunedin 9054
Country 89567 0
New Zealand
Phone 89567 0
+64 3 470 9850
Fax 89567 0
Email 89567 0
[email protected]
Contact person for scientific queries
Name 89568 0
Kari Clifford
Address 89568 0
University of Otago
Department of Surgical Sciences
Dunedin School of Medicine
PO Box 56
Dunedin 9054
Country 89568 0
New Zealand
Phone 89568 0
+64 3 470 9850
Fax 89568 0
Email 89568 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified raw data will be available on request at the discretion of the investigators.
When will data be available (start and end dates)?
Data will be made available once the study results have been published. They will be available for ten years following study completion.
Available to whom?
Data will be made available on a case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
Data will be available only to achieve the aims in the approved proposal.
How or where can data be obtained?
Access to data will be subject to approvals by emailing the Principal Investigator ([email protected]) and will include a requirement to sign a data access agreement.


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.