Trial Review

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
ACTRN12625000821493
Ethics application status
Approved
Date submitted
24/06/2025
Date registered
31/07/2025
Date last updated
31/07/2025
Date data sharing statement initially provided
31/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Validation of a lab test to guide dietary management of patients with an ileoanal pouch
Scientific title
Validation of a lab test to guide dietary management of patients with an ileoanal pouch
Secondary ID [1] 314731 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
This is a follow on study from: ACTRN12624000912583

Health condition
Health condition(s) or problem(s) studied:
Inflammatory bowel disease 337934 0
Ileo-anal pouch 337935 0
J pouch 338032 0
Ileal pouch 338033 0
Condition category
Condition code
Oral and Gastrointestinal 334257 334257 0 0
Inflammatory bowel disease
Surgery 334258 334258 0 0
Other surgery
Diet and Nutrition 334259 334259 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Phase 1 (Trial ID: ACTRN12624000912583) involved a laboratory-based study using fresh stool samples to validate an in vitro assay that measures microbial fermentation of different dietary components. This assay uses a gas-sensing system to quantify fermentation but is not a diagnostic tool, nor is it intended to monitor, treat, or prevent disease. All participants in the current study have already taken part in Phase 1.

Phase 2 (this study) is a randomised, crossover dietary intervention designed to assess whether the in vitro assay can reflect diet-induced changes in fermentation. Participants will complete two 7-day dietary periods that differ in their food composition, separated by a 3-week washout period.
Before starting the diets, participants will complete a 3-day habitual diet “run-in” period. They will then be randomised to follow one of the two diets. After the first 7-day diet, a washout period of at least 3 weeks will occur before switching to the second diet for another 7 days.

Participants will be provided with food hampers that include both pre-prepared items and ingredients to prepare themselves, covering three meals and snacks per day. The study coordinator (a dietitian) will deliver dietary education via a tailored written handout and a brief verbal session (in person or via phone, depending on participant availability). The education materials have been developed specifically for this study.
To support adherence, participants will complete a daily food diary.
Participants will provide a total of three stool samples during this study:
1. After the 3-day habitual diet run-in period
2. At the end of the first 7-day diet period
3. At the end of the second 7-day diet period

If successful, this work may help support more personalised dietary recommendations for individuals with an ileoanal pouch.
Intervention code [1] 331335 0
Treatment: Other
Comparator / control treatment
Participants will receive a diet that is low in the food component of interest
Control group
Active

Outcomes
Primary outcome [1] 341928 0
Percentage of fermentable fibre utilisation
Timepoint [1] 341928 0
Baseline and at the end of each 7 day dietary intervention
Secondary outcome [1] 449028 0
Amount of fibre leftover in stool
Timepoint [1] 449028 0
At the end of each 7 day dietary intervention
Secondary outcome [2] 449030 0
Tolerability
Timepoint [2] 449030 0
At the end of each 7 day dietary intervention
Secondary outcome [3] 449031 0
Gastrointestinal transit time
Timepoint [3] 449031 0
At the end of each 7 day dietary intervention
Secondary outcome [4] 449033 0
Bloating
Timepoint [4] 449033 0
At the end of 7 day dietary intervention
Secondary outcome [5] 449034 0
Faecal calprotecrin
Timepoint [5] 449034 0
At the end of each 7 day dietary intervention
Secondary outcome [6] 449036 0
Baseline dietary intake
Timepoint [6] 449036 0
At the end of each 7 day dietary intervention
Secondary outcome [7] 449803 0
FODMAP and Resistant starch intake
Timepoint [7] 449803 0
At the end of each 7 day dietary intervention
Secondary outcome [8] 449804 0
Abdominal pain
Timepoint [8] 449804 0
At the end of each 7 day dietary intervention
Secondary outcome [9] 449805 0
Flatulence
Timepoint [9] 449805 0
At the end of each 7 day dietary intervention

Eligibility
Key inclusion criteria
Patients will undergo screening prior to obtaining informed consent for the following criteria:
• Aged 18-75 years old
• Patients with an ileo-anal pouch
• English speaking
• Eligible for Medicare
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients with antibiotic dependent or antibiotic refractory pouchitis
• Use of fibre supplements within 2 weeks
• Active pouchitis
• History of Crohn’s disease
• Inability to provide informed consent
• Dietary restrictions, food allergies, intolerances or aversions that will interfere with consuming intervention foods (i.e. veganism, vegetarian, food allergies)
• Use of antibiotics, pre or probiotics within the last 4 weeks
• History of stricturing ileal or pouch inlet disease
• History of recent small bowel obstructions (in the last 2 years)

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible patients will be randomly allocated via a simple randomisation sequence made using Graphpad
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/08/2025
Actual
Date of last participant enrolment
Anticipated
15/08/2026
Actual
Date of last data collection
Anticipated
26/09/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 28147 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 44353 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 319283 0
Government body
Name [1] 319283 0
NHMRC
Country [1] 319283 0
Australia
Funding source category [2] 319284 0
University
Name [2] 319284 0
Monash University Department of Gastroenterology Departmental funds
Country [2] 319284 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 321757 0
None
Name [1] 321757 0
Address [1] 321757 0
Country [1] 321757 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317860 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 317860 0
Ethics committee country [1] 317860 0
Australia
Date submitted for ethics approval [1] 317860 0
24/03/2025
Approval date [1] 317860 0
08/05/2025
Ethics approval number [1] 317860 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 142386 0
Dr Chu Yao
Address 142386 0
Monash University Level 6, 99 Commercial Rd Melbourne VIC 3004
Country 142386 0
Australia
Phone 142386 0
+61 3 9903 0266
Fax 142386 0
Email 142386 0
[email protected]
Contact person for public queries
Name 142387 0
Dakota Rhys-Jones
Address 142387 0
Monash University, Level 6, 99 Commercial Rd Melbourne VIC 3004
Country 142387 0
Australia
Phone 142387 0
+61 3 9903 0367
Fax 142387 0
Email 142387 0
[email protected]
Contact person for scientific queries
Name 142388 0
Dakota Rhys-Jones
Address 142388 0
Monash University Level 6, 99 Commercial Rd Melbourne VIC 3004
Country 142388 0
Australia
Phone 142388 0
+61 3 9903 0367
Fax 142388 0
Email 142388 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    117491 (Local Reference 235-25) Ethics Approval Certificate 8-May-2025.pdf


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.