ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Inflammatory bowel disease

familial adenomatous polyposis

Ileoanal pouch

Pouchitis

Colectomy

Ulcerative colitis

ileal pouch-anal anastomosis

Condition category

Condition code

Oral and Gastrointestinal

Inflammatory bowel disease

Human Genetics and Inherited Disorders

Other human genetics and inherited disorders

Diet and Nutrition

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]

Not applicable

Comparator / control treatment

N/a

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Incidence of pouchitis

Timepoint [1]

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]

Change of pouchitis phenotype

Timepoint [2]

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]

Incidence of irritable pouch syndrome

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Alfred - Melbourne

Recruitment postcode(s) [1]

3004 - Melbourne

Funding & Sponsors

Funding source category [1]

University

Name [1]

Monash University

Address [1]

99 Commercial Rd Melbourne Vic 3004

Country [1]

Australia

Primary sponsor type

University

Name

Monash University

Address

99 Commercial Rd Melbourne Vic 3004

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Hospital Ethics Committee

Ethics committee address [1]

55 Commercial Rd Melbourne Vic 3004

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

24/08/2023

Approval date [1]

09/11/2023

Ethics approval number [1]

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

Dr Zaid Ardalan

Address

Monash University, Level 6, 99 Commercial Rd Melbourne Vic 3004

Country

Australia

Phone

+61 409730301

Fax

z.ardalan@alfred.org.au

Contact person for public queries

Name

Dakota Rhys-Jones

Address

Monash University, Level 6, 99 Commercial Rd Vic Melbourne 3004

Country

Australia

Phone

+61 03 99030367

Fax

dakota.rhys-jones@monash.edu

Contact person for scientific queries

Name

Zaid Ardalan

Address

Monash University, Level 6, 99 Commercial Rd Melbourne Vic 3004

Country

Australia

Phone

+61 409730301

Fax

z.ardalan@alfred.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
21093	Informed 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

No additional documents have been identified.

Trial Review

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