Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000016538
Ethics application status
Approved
Date submitted
30/11/2023
Date registered
10/01/2024
Date last updated
10/01/2024
Date data sharing statement initially provided
10/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Dietary and lifestyle predictors of pouchitis
Scientific title
Longitudinal study of diet, lifestyle and biomarker predictors of pouchitis
Secondary ID [1] 311165 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory bowel disease 332205 0
familial adenomatous polyposis 332206 0
Ileoanal pouch 332207 0
Pouchitis 332208 0
Colectomy 332209 0
Ulcerative colitis 332333 0
ileal pouch-anal anastomosis 332334 0
Condition category
Condition code
Oral and Gastrointestinal 328918 328918 0 0
Inflammatory bowel disease
Human Genetics and Inherited Disorders 328919 328919 0 0
Other human genetics and inherited disorders
Diet and Nutrition 328921 328921 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We will be following individuals with an ileoanal pouch over 18 months to identify if dietary factors or psychological stress are environmental factors that can predict the onset or worsening of pouchitis. Participants will complete 3-day food diaries, complete a series of online questionnaires related to their pouch function and stress as well as collecting biological samples. Data will be collected online every 6 months, and biological samples will be collected at home and posted back to researchers.

Secondly, from the data we collected, we will be assessing how useful faecal calprotectin can be used as a prognostic marker for the development or worsening of pouchitis. In order to achieve this, we will be collecting information about what participants eat, how their pouch functions, their stress levels and psychological wellbeing.

Faecal calprotectin in their stools will be collected and hair samples as a retrospective way of looking at the stress hormone, cortisol to identify chronic stress. Dietary intake will be assessed on its overall ‘healthfulness’ and used to find underlying relationships with pouchitis.
Intervention code [1] 327515 0
Not applicable
Comparator / control treatment
N/a
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336722 0
Incidence of pouchitis
Timepoint [1] 336722 0
Timepoints relevant to participation are: baseline, 6 months, 12 months, 18 months. We will also collect information at 3 monthly intervals if pouchitis has developed.
Primary outcome [2] 336723 0
Change of pouchitis phenotype
Timepoint [2] 336723 0
Timepoints relevant to participation include baseline, 6 months, 12 months, 18 months. We will also collect information at 3 monthly intervals related to changes in pouch function.
Secondary outcome [1] 429476 0
Incidence of irritable pouch syndrome
Timepoint [1] 429476 0
Timepoints relevant to participation include baseline, 6 months, 12, months, 18 months. We will also collect information at 3 monthly intervals related to changes in pouch function.

Eligibility
Key inclusion criteria
• Living with an ileoanal pouch
• 18-75 years old
• Living in Australia,
• Ability to speak and read English
• Eligible for Medicare
• Internet access
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Chronic antibiotic refractory pouchitis (pouchitis refractory to combination antibiotics for greater than or equal to 4 weeks)
• Inability to provide informed consent

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Targeted number to recruit: 82 participants as outlined below.

Power calculations (based on Poisson regression) suggests that a minimum sample size of 82 participants completing all 4 time points and therefore, a total of 328 observations will be needed based on an effect size of 1.333, 80% power, two-tailed and a total of 6 predictors. A 20% drop out rate was also included in the sample size calculation. Given this patient cohort is rare, this sample size may be difficult to achieve but we will aim to recruit as many participants as possible to meet the sample size, expanding recruitment to multiple clinical sites across Australia.

Predictive modelling:
Several statistical modelling approaches will be used to assess the relationship between predictors and development / worsening of pouchitis:

A Poisson regression will be used to analyse the relationship between predictors and worsening/development of pouchitis. To do so, each pouchitis episode in the last 6 months will be considered a count and a count distribution will be generated at the end of every - month intervals. These counts will be added up to provide a total count of pouchitis episodes over a 12-month period to yield a mean average of pouchitis episodes. Mean average of pouchitis episodes will be compared between tertiles of intake / levels for each predictor. Risk ratios will be generated.
In addition, the impact of each predictor (whilst controlling for all other predictors) on the count distribution of pouchitis episodes will also be evaluated using marginal means.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/01/2024
Actual
Date of last participant enrolment
Anticipated
1/07/2025
Actual
Date of last data collection
Anticipated
8/07/2025
Actual
Sample size
Target
82
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25897 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 41732 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 315325 0
University
Name [1] 315325 0
Monash University
Country [1] 315325 0
Australia
Primary sponsor type
University
Name
Monash University
Address
99 Commercial Rd Melbourne Vic 3004
Country
Australia
Secondary sponsor category [1] 317379 0
None
Name [1] 317379 0
Address [1] 317379 0
Country [1] 317379 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314246 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 314246 0
55 Commercial Rd Melbourne Vic 3004
Ethics committee country [1] 314246 0
Australia
Date submitted for ethics approval [1] 314246 0
24/08/2023
Approval date [1] 314246 0
09/11/2023
Ethics approval number [1] 314246 0
472/23

Summary
Brief summary
Pouchitis is the most common inflammatory condition for those living with an ileoanal pouch (whereby the large bowel is removed due to medically unresponsive ulcerative colitis (UC) or familial adenomatous polyposis (FAP) and its cause is largely unknown.

We aim to assess whether specific diet components and psychological factors such as stress can predict pouchitis. We also aim to assess whether faecal calprotectin (a marker of inflammation found in faeces) can be used as a test to predict worsening in pouch function or pouchitis.

This study will follow patients with an ileoanal pouch prospectively for 18 months to evaluate if diet, stress and faecal calprotectin play a role in predicting pouchitis or worsening of pouchitis. This is important because there are currently no dietary guidelines to help ileoanal pouch patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130922 0
Dr Zaid Ardalan
Address 130922 0
Monash University, Level 6, 99 Commercial Rd Melbourne Vic 3004
Country 130922 0
Australia
Phone 130922 0
+61 409730301
Fax 130922 0
Email 130922 0
z.ardalan@alfred.org.au
Contact person for public queries
Name 130923 0
Ms Dakota Rhys-Jones
Address 130923 0
Monash University, Level 6, 99 Commercial Rd Vic Melbourne 3004
Country 130923 0
Australia
Phone 130923 0
+61 03 99030367
Fax 130923 0
Email 130923 0
dakota.rhys-jones@monash.edu
Contact person for scientific queries
Name 130924 0
Dr Zaid Ardalan
Address 130924 0
Monash University, Level 6, 99 Commercial Rd Melbourne Vic 3004
Country 130924 0
Australia
Phone 130924 0
+61 409730301
Fax 130924 0
Email 130924 0
z.ardalan@alfred.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21093Informed consent form    386966-(Uploaded-30-11-2023-10-17-32)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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