Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000190404
Ethics application status
Approved
Date submitted
22/01/2025
Date registered
18/02/2025
Date last updated
18/02/2025
Date data sharing statement initially provided
18/02/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised double-blinded placebo-controlled trial of therapeutic diet in patients with an ileal pouch anal anastomosis (IPAA)
Scientific title
A randomised double-blinded placebo-controlled trial of the efficacy of therapeutic diet on clinical symptoms in patients with an ileal pouch anal anastomosis (IPAA)
Secondary ID [1] 313848 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pouchitis 334285 0
Condition category
Condition code
Oral and Gastrointestinal 332014 332014 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will attend a 1h session with the research dietitian to familiarise themselves with the dietary intervention at week baseline. They will then be sent all their food for the duration of the study in boxes of meals and frozen meals on a weekly basis for the 7 week intervention period. This will include a 1 week initial adaptation phase where they gradually increase their intake of fermentable fibre followed by a 6-week diet intervention. The study diets were designed by a research dietitian with expertise in dietary interventions for pouch patients in conjunction with the research chef.

The intervention diet consists of 5 principles:
(1) A higher amount of readily fermentable fibre content (6g of oligosaccharides and 10g of resistant starch)
(2) A reduced intake of foods high in excess fructose and polyols (<1.5 g/d) as used in previous dietary studies.
(3) A daily protein intake; within the Australian guide to healthy eating / nhmrc RDI for protein intake
(4) Limiting animal protein and concentrated protein sources as major of sources of sulphur containing amino acids whilst allowing intake of most dairy, legumes and plant-based protein sources as the main staples (to 30-40% of the daily protein intake)
(5) Minimising intake of food preservatives derived from sulphates and sulphites. Suitable preservative-free products will be used instead.

Adherence to the intervention will be monitored using food diary checklists and via direct questioning by the research dietitian.
Intervention code [1] 329743 0
Treatment: Other
Comparator / control treatment
The control diet will consist of a typical Australian pouch diet, designed to mimic typical dietary patterns of Australian individuals with ileoanal pouches so as not to modify their intake of the dietary components of interest in the Monash Pouch Diet diet. Nutritional targets were generated from a survey of dietary habits of Australian patients with ileoanal pouches. The typical Australian pouch diet provided contained a moderate amount of readily fermentable fibre (3 g oligosaccharides, 3-4 g of resistant starch), a high amount of protein ~120g with majority derived from animal protein and high levels (~8 g /d) of osmotically-active carbohydrates, excess fructose and polyols. Participants will also undergo a 1-week adaptation period to preserve blinding where we will gradually increase their total fibre intake.
Control group
Active

Outcomes
Primary outcome [1] 340385 0
The proportion of patients achieving symptomatic remission defined as a clinical Pouch Disease Activity Index (PDAI) subscore less than or equal to 2
Timepoint [1] 340385 0
Baseline and end of study (7 week timepoint).
Secondary outcome [1] 443921 0
Change from baseline of pouch inflammation via the endoscopic and histopathological scores as a composite secondary outcome
Timepoint [1] 443921 0
Baseline and week 7 timepoint (end of study)
Secondary outcome [2] 443924 0
Satisfaction with the Monash Pouch Diet using a Diet Satisfaction Score (DSS) questionnaire
Timepoint [2] 443924 0
Baseline and week 7 timepoint (end of study)
Secondary outcome [3] 443919 0
The proportion of patients with clinical response (a reduction of total PDAI by less than or equal to 3)
Timepoint [3] 443919 0
Baseline and week 7 timepoint (end of study)
Secondary outcome [4] 443918 0
The proportion of patients in clinical remission (clinical PDAI score less than or equal to 2 and endoscopic activity less than or equal to 1 and histologic score of less than or equal to 1 and a total PDAI less than or equal to 4)
Timepoint [4] 443918 0
Baseline and week 7 (end of study)
Secondary outcome [5] 443916 0
the proportion of patients with symptomatic improvement (reduction of clinical PDAI subscore by less than or equal to 2)
Timepoint [5] 443916 0
Baseline and week 7 (end of study)
Secondary outcome [6] 443920 0
change from baseline of symptoms (clinical PDAI)
Timepoint [6] 443920 0
Baseline and week 7 timepoint (end of study)
Secondary outcome [7] 443917 0
Endoscopic improvement (reduction of endoscopic PDAI by greater than or equal to 2)
Timepoint [7] 443917 0
Baseline and week 7 (end of study)
Secondary outcome [8] 443923 0
Changes in health-related quality of life assessed by Cleveland Global Quality of Life (CGQL) questionnaire
Timepoint [8] 443923 0
Baseline and Week 7 (end of study)
Secondary outcome [9] 443922 0
Change from baseline of pouch inflammation via faecal calprotectin
Timepoint [9] 443922 0
Baseline and week 7 timepoint (end of study)
Secondary outcome [10] 444970 0
Changes in health-related quality of life assessed by the generic 36-Item Short Form Survey Instrument (SF-36).
Timepoint [10] 444970 0
Baseline and week 7 timepoint (end of study)

Eligibility
Key inclusion criteria
Patients with ileoanal pouch and a history of pouchitis
Clinical Pouch Disease Activity Index (PDAI) greater than or equal to 3
Age 18-75 years
Naïve or have limited prior knowledge for implementing a 5URE diet
Amenable to complying to a dietary intervention
Eligible for Medicare
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to provide informed consent
No history of pouchitis
Clinical PDAI <3
Coeliac disease
History of stricturing ileal or pouch inlet disease
History of small bowel obstructions in the last 2 years
Recent change, in the last 4 weeks of pouch-directed therapies, including oral or intravenous antibiotics, amino-salicylates, corticosteroids, immunosuppressive agents (thiopurines, methotrexate), and biologic agents (infliximab, adalimumab, ustekinumab, vedolizumab)
Use of fibre, probiotic and/or prebiotic in the last 4 weeks
Individuals following a predominantly plant-based or vegan diet
Individuals not following a stable diet for less than 4 weeks
Pregnancy, trying to become pregnant, breastfeeding.

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 concealment was carried out using central randomisation by a computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible patients will be stratified according to pouch phenotype and activity, before being randomly assigned in a 1:1 ratio to receive either the intervention diet or placebo. The stratified randomisation will be performed according to a computer-generated randomization schedule with permuted blocks
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
The study was prematurely terminated due to deteriorating outcomes across both arms.
Date of first participant enrolment
Anticipated
Actual
25/01/2021
Date of last participant enrolment
Anticipated
Actual
5/04/2021
Date of last data collection
Anticipated
1/03/2025
Actual
17/05/2021
Sample size
Target
64
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 43603 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 318193 0
Charities/Societies/Foundations
Name [1] 318193 0
International Organisation for the Study of IBD
Country [1] 318193 0
Netherlands
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 320578 0
None
Name [1] 320578 0
Address [1] 320578 0
Country [1] 320578 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316843 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 316843 0
Ethics committee country [1] 316843 0
Australia
Date submitted for ethics approval [1] 316843 0
10/06/2020
Approval date [1] 316843 0
16/09/2020
Ethics approval number [1] 316843 0

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

Contacts
Principal investigator
Name 48230 0
Prof Peter Gibson
Address 48230 0
Department of Gastroenterology Monash University Level 6, 99 Commercial Rd, Melbourne VIC 3004
Country 48230 0
Australia
Phone 48230 0
+61 399030260
Fax 48230 0
Email 48230 0
[email protected]
Contact person for public queries
Name 48231 0
Dr Chu K Yao
Address 48231 0
Department of Gastroenterology Monash University Level 6, 99 Commercial Rd, Melbourne VIC 3004
Country 48231 0
Australia
Phone 48231 0
+61 399030266
Fax 48231 0
Email 48231 0
[email protected]
Contact person for scientific queries
Name 48232 0
Dr Chu K Yao
Address 48232 0
Department of Gastroenterology Monash University Level 6, 99 Commercial Rd, Melbourne VIC 3004
Country 48232 0
Australia
Phone 48232 0
+61 399030266
Fax 48232 0
Email 48232 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: This was not included in the initial ethical application



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.