Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000577415
Ethics application status
Approved
Date submitted
5/05/2025
Date registered
4/06/2025
Date last updated
4/06/2025
Date data sharing statement initially provided
4/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Augmenting treatment response with an Anti-Inflammatory diet in Ulcerative Colitis.
Scientific title
The Augmentation of Salofalk Efficacy in Ulcerative Colitis Through an Anti-Inflammatory Diet: An exploratory double-blinded randomised feeding trial
Secondary ID [1] 314366 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 337366 0
Condition category
Condition code
Oral and Gastrointestinal 333749 333749 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dietary Intervention:
The Modified Anti-Inflammatory Diet (MAID) will be designed based on the latest evidence for dietary interventions in ulcerative colitis (UC), focusing on high fibre content; low processed and red meats; an increase in fermented foods and minimal food additives and emulsifiers.
Each participant will receive two meals per day (lunch and dinner) for 8 weeks, prepared by a professional chef in a commercial-grade kitchen. Frozen meals will be delivered directly to participants' homes to promote adherence and prevent potential biases introduced by self-reported dietary intake.
After 8 weeks, participants will be unblinded and offered an appointment with a dietitian during where 30 mins of MAID dietary education will be provided, advising them how to shop, cook, and prepare meals for an 8-week follow-up study.
Drug Intervention:
5aminosalicylate treatment oral +/- rectal.
Participants in both dietary interventions will be started on an optimal dose of 5aminosalicylate (5ASA) using 3 g orally once daily. Salofalk granules, which will be maintained for the duration of the 16-week study. Patients will be assessed on a weekly basis by the clinical research team. After 4 weeks of treatment, those with no improvement in rectal bleeding and stool frequency (defined as an Simple colitis clinical activity index (SCCAI) score for rectal bleeding greater than or equal to 2 and daytime bowel frequency of greater than or equal to 1. ) can have topical 5-ASA therapy added to the existing oral regimen. This topical 5-ASA regimen must be either Salofalk 1g foam or Salofalk 1g suppositories, based on the patients UC phenotype. The Salofalk granules regimen will be maintained at 3g per day, even if this topical therapy is added.
Adherence monitoring:
Dietary Diaries: Baseline dietary intake will be recorded using a 3-day diet diary, completed via the Easy Diet Diary app (Xyris Software Australia Pty Ltd 2020) or a paper diary, based on participant preference. A second 3-day diet diary will be completed during week 16 to monitor dietary adherence. Dietary intake will include household serves and weighed food measurements including details about ingredients, brands of food and cooking methods. During week 0 to 8 a weekly diet checklist will be completed.
Adherence Monitoring: The use of meal delivery services and dietary diaries will help promote high adherence to the intervention and accurately assess dietary compliance. Adherence to drug therapy will primarily be monitored by asking participants to bring their remaining medication to their week 8 and week 16 study visits. A member of the study team will count the remaining packs and compare this with the number issued at the baseline visit.
Intervention code [1] 330985 0
Treatment: Other
Intervention code [2] 331106 0
Treatment: Drugs
Comparator / control treatment
Dietary Intervention:
A sham diet: The sham diet will be calorically-matched to the MAID but will conform to a standard Australian diet – this reflects a Western dietary pattern with low fibre and high intakes of processed foods, emulsifiers, additives, sugar and artificial sweeteners.
Each participant will receive two meals per day (lunch and dinner) for 8 weeks, prepared by a professional chef in a commercial-grade kitchen. Frozen meals will be delivered directly to participants' homes to promote adherence and prevent potential biases introduced by self-reported dietary intake.
After 8 weeks, participants will be unblinded and offered an appointment with a dietitian during where 30 mins of MAID dietary education will be provided, advising them how to shop, cook, and prepare meals for an 8-week follow-up study.
Drug Intervention:
5aminosaliclyate treatment oral +/- rectal
Participants in both dietary interventions will be started on an optimal dose of 5ASA using 3 g oreally once daily. Salofalk granules, which will be maintained for the duration of the 16-week study. Patients will be assessed on a weekly basis by the clinical research team. After 4 weeks of treatment, those with no improvement in rectal bleeding and stool frequency (defined as an SCCAI score for rectal bleeding greater than or equal to 2 and daytime bowel frequency of greater than or equal to 1) can have topical 5-ASA therapy added to the existing oral regimen. This topical 5-ASA regimen must be either Salofalk 1g foam or Salofalk 1g suppositories, based on the patients UC phenotype. The Salofalk granules regimen will be maintained at 3g/day, even if this topical therapy is added.
Control group
Placebo

Outcomes
Primary outcome [1] 341333 0
Since this is an exploratory study, all outcome measures are considered as such, with a view to generating hypotheses for further study. However the primary outcome will be: Asses whether a Modified Anti-Inflammatory Diet (MAID) can augment treatment response to 5ASAs in mild to moderate ulcerative colitis compared to a sham diet.
Timepoint [1] 341333 0
This will be assessed at baseline, week 8 (post-completion of controlled feeding trial) and week 16 (after completion of 8 weeks real-world implementation).
Primary outcome [2] 341638 0
Since this is an exploratory study, all outcome measures are considered as such, with a view to generating hypotheses for further study. However the primary outcome will be: Asses whether a Modified Anti-Inflammatory Diet (MAID) can augment treatment response to 5ASAs in mild to moderate ulcerative colitis compared to a sham diet (clinically, biochemically and endoscopically).
Timepoint [2] 341638 0
This will be assessed at baseline, week 8 (post-completion of controlled feeding trial) and week 16 (after completion of 8 weeks real-world implementation).
Primary outcome [3] 341639 0
Since this is an exploratory study, all outcome measures are considered as such, with a view to generating hypotheses for further study. However the primary outcome will be: Asses whether a Modified Anti-Inflammatory Diet (MAID) can augment treatment response to 5ASAs in mild to moderate ulcerative colitis compared to a sham diet (clinically, biochemically and endoscopically).
Timepoint [3] 341639 0
This will be assessed at baseline and week 8 (post-completion of controlled feeding trial).
Secondary outcome [1] 447161 0
Evaluate whether a Modified Anti-Inflammatory Diet (MAID) can improve quality of life in mild to moderate ulcerative colitis compared to a sham diet.
Timepoint [1] 447161 0
At baseline, week 8 (post-completion of controlled feeding trial) and week 16 (after completion of 8 weeks real-world implementation).
Secondary outcome [2] 447847 0
Explore the qualitative and quantitative differences in faecal microbiome composition. This will be assessed as a composite secondary outcome.
Timepoint [2] 447847 0
This will be assessed at baseline, week 8 (post-completion of controlled feeding trial) and week 16 (after completion of 8 weeks real-world implementation).
Secondary outcome [3] 447848 0
Explore the qualitative and quantitative differences in faecal metabolome profiles. This will be assessed as a composite secondary outcome.
Timepoint [3] 447848 0
This will be assessed at baseline, week 8 (post-completion of controlled feeding trial) and week 16 (after completion of 8 weeks real-world implementation).
Secondary outcome [4] 447849 0
Explore the changes in intestinal permeability. This will be assessed as a composite secondary outcome.
Timepoint [4] 447849 0
This will be assessed at baseline, week 8 (post-completion of controlled feeding trial) and week 16 (after completion of 8 weeks real-world implementation).

Eligibility
Key inclusion criteria
i) Provide signed and dated informed consent
ii) Willing to comply with all study procedures and be available for the duration of the study
iii) Age greater than or equal to 18 years old, less than or equal to 65 years old
iv) New diagnosis of UC
v) Mild-moderately active UC as assessed by a baseline Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score 2-6
vi) All patients will be treatment naïve
vii) BMI 35kg/m2
viii) Renal function and liver function acceptable for initiation and continuation of mesalazine during study period (liver function: AST ALT 60ml/min).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) Severe ulcerative colitis with SCCAI greater than or equal to 8 OR UCEIS greater than or equal to 7 OR hospitalization for acute severe colitis (ASUC) in the previous 6 months
ii) Crohn's disease and indeterminate colitis
iii) Pregnancy or lactation
iv) Active infection
v) Exposure to antibiotics, probiotics, prebiotics, corticosteroids or other therapies known to affect gastrointestinal function (including laxatives, fibre supplements, proton pump inhibitors, non-steroidal anti-inflammatory drugs (NSAIDs)) within 4 weeks of enrolment.
vi) Individuals who are malnourished, as determined by an overall Subjective Global Assessment (SGA) rating of B or C.
vii) Individuals who are not able to comply with the dietary intervention such as individuals who are vegetarian, vegan or adhere to a restrictive dietary pattern.
viii) Individuals not willing to co-recruit into the Australian IBD Microbiome (AIM) study
ix) Diverticular disease (defined as a confluent segment of diverticula between the proximal rectum and the distal descending colon with luminal distortion).

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)
A study investigator will complete a randomisation form on REDCap which will generate a sequential number and randomise participants to the MAID or sham diet group. The algorithm for the randomisation form will be designed and uploaded independently into REDCap by a statistician.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be recruited and randomised 1:1 to either the MAID or sham diet groups. Randomisation will be stratified based on i) disease extent (E1, E2, E3) ii) degree of inflammation at diagnosis, as measured using the Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score and iii) habitual diet, as assessed by the Australian Eating Survey. This stratification ensures balanced distribution of disease severity and dietary habits across the intervention groups.
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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/01/2026
Actual
Date of last participant enrolment
Anticipated
21/12/2026
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 318888 0
Commercial sector/Industry
Name [1] 318888 0
Dr Falk Pharma
Country [1] 318888 0
Australia
Primary sponsor type
Hospital
Name
RBWH, Metro North Health Services
Address
Country
Australia
Secondary sponsor category [1] 321354 0
None
Name [1] 321354 0
Address [1] 321354 0
Country [1] 321354 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317506 0
Metro North Health Human Research Ethics Committee A
Ethics committee address [1] 317506 0
Ethics committee country [1] 317506 0
Australia
Date submitted for ethics approval [1] 317506 0
03/04/2025
Approval date [1] 317506 0
28/04/2025
Ethics approval number [1] 317506 0

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

Contacts
Principal investigator
Name 141258 0
A/Prof Gareth Walker
Address 141258 0
Royal Brisbane and Women's Hospital, Department of Gastroenterology and Hepatology, Butterfield Street, Herston, 4006, QLD
Country 141258 0
Australia
Phone 141258 0
+61 0736470335
Fax 141258 0
Email 141258 0
[email protected]
Contact person for public queries
Name 141259 0
Gareth Walker
Address 141259 0
Royal Brisbane and Women's Hospital, Department of Gastroenterology and Hepatology, Butterfield Street, Herston, 4006, QLD
Country 141259 0
Australia
Phone 141259 0
+61 0736470335
Fax 141259 0
Email 141259 0
[email protected]
Contact person for scientific queries
Name 141260 0
Gareth Walker
Address 141260 0
Royal Brisbane and Women's Hospital, Department of Gastroenterology and Hepatology, Butterfield Street, Herston, 4006, QLD
Country 141260 0
Australia
Phone 141260 0
+61 0736470335
Fax 141260 0
Email 141260 0
[email protected]

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


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.