Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000513415
Ethics application status
Approved
Date submitted
24/04/2025
Date registered
23/05/2025
Date last updated
23/05/2025
Date data sharing statement initially provided
23/05/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
A prospective, four-step interventional cohort treat-to-target study assessing the impact of a stepped diet program on faecal calprotectin and CRP in Crohn’s disease.
Scientific title
DELECTABLE 2.0 Program: A prospective, four-step interventional cohort treat-to-target study assessing the impact of a stepped diet program on faecal calprotectin and CRP in Crohn’s disease
Secondary ID [1] 314240 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 337208 0
Condition category
Condition code
Oral and Gastrointestinal 333619 333619 0 0
Inflammatory bowel disease
Oral and Gastrointestinal 333713 333713 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treat-to-target, step-up program of up to 4 diets, which increase in prescriptiveness, as sole or adjunctive therapy for Crohn’s disease. Step 1: Wholefood, Mediterranean-style diet. Step 2: Phase 2 of the Crohn’s Disease Exclusion Diet (CDED); Step 3: Phase 1 of the CDED; Step 4: A formulated, liquid only diet, known as Exclusive Enteral Nutrition (EEN).


All interventions will be administered by dietitians. Dietitians will provide education materials and a meal plan. Liquid nutrition formula will be provided on EEN, but food will not be provided. Patients will have in-person visits with a dietitian at Baseline, end of Week 1, End of Week 6, End of Week 12, 6 months will follow up (completion of questionnaires) at 12 months. 24 months, and 2-yearly thereafter for up to 10 years or as long as clinically relevant.

The assessment criteria for step up to the next phase diet at each 6 weekly visit is FAILURE to meet the following definition of response (primary endpoint criteria): Biochemical response (faecal calprotectin decrease of more than or equal to 50% from baseline or to less than or equal to 100ug/L OR CRP decrease by more than or equal to 50% or reaching normal level).

We will assess biomarkers to determine participant response after 6 weeks on the diet, to determine if the participant will move to the next diet phase due to non-response. Alternatively, a clinical response has occurred, the patient will be transitioned to the wholefood diet for maintenance therapy, which does not exclude any food groups, and is in concordant with the Australian Guide to Healthy Eating. Dietary intensification will be immediate (no washout-our ot run-in period)

That is, the maximum time on any one of the four therapeutic will be 12 weeks, and the maximum total time of active intervention will be 24 weeks. All patients will have at least 12 weeks of active intervention. Patients will follow allocated diet for entire time they are allocated to that diet arm (all meals and snacks).


Step 1: Additive Free, Wholefood (Mediterranean Style) Diet
This diet was designed by the researchers.
The main focus of this diet is the exclusion of added chemicals and additives in food. Most processed foods contain chemicals to make them look better, last longer, or taste different. Many of these chemicals, however, are known to be pro-inflammatory. Foods can be classified in tiers of processing by the NOVA classification.

Natural (unprocessed) foods are allowed. Natural foods include fresh, chilled and frozen fruits and vegetables; legumes such as beans and lentils; nuts and seeds; fresh meat, poultry and fish; eggs; milk and some yoghurts. Grains, such as oats, rice, polenta and quinoa and flours/flakes/pastas made from grains are also considered natural as although they have undergone some mechanical processing, they generally contain no chemical additives.

Processed food ingredients generally do not contain added chemicals and can be kept in the diet. These are usually used to cook fresh foods and are rarely consumed alone. Examples include olive oil and other vegetable oils (sunflower, canola, etc.), salt, sugar, honey and vinegar. Processed foods with these minor additions (i.e., salt, sugar oil) but no chemicals can also be kept in the diet. Examples include some corn chips, potato crisps, nut butters, and certain crackers/breads/breakfast cereals.

Processed foods often contain additives to preserve their original properties or prevent spoilage. Examples include tinned vegetables and fruits, cured meats, cheese and bread. The labels of these foods need to be checked before deciding if they are acceptable to consume on this diet.

Ultra-processed foods (NOVA group 4) have long lists of unrecognisable ingredients and added chemicals with minimal intact, natural foods. Examples include fizzy drinks, packaged snacks, ice-cream, chocolate, packaged breads, margarines, biscuits, pastries, cakes, and chicken and fish ‘nuggets’ and ‘sticks’, sausages and burgers. These foods should be completely avoided.

In addition to recommending avoidance of dietary additives, this diet recommends reduced consumption of red meat (1/week), with a focus on chicken, eggs and legumes as protein sources; reduced consumption of wheat-containing products (1/day), with a focus on consuming a diverse range of wholegrains; low moderate alcohol consumption; use of monounsaturated fatty acids (e.g. olive oil) in cooking; and inclusion of unprocessed fruit, vegetables and dairy daily.

The Additive Free, Wholefood (Mediterranean Style) Diet will be utilised as the first entry point therapeutic diet option and the maintenance dietary therapy.

Step 2 (Phase 1 of CDED) and Step 3 (Phase 2 of CDED)
The Crohn’s Disease Exclusion Diet (CDED) is a 3-phase diet. The diet mainly focuses on:
• Avoidance of added chemicals
• Inclusion of high-quality, low-fat protein (mostly chicken and eggs)
• Inclusion of resistant starch and specific fibres (apples, bananas, potatoes)
• Use of liquid supplements to help meet energy and nutrient needs
In addition, the diet limits dairy, wheat, oats, quinoa, red meat, and fish. These must be completely avoided in the first six weeks and consumed in restricted amounts long term. Certain fruits and vegetables are also restricted in the initial phase of the diet. The diet becomes less restrictive as you move through the phases.
In brief:
Phase 1: Follow for 6 weeks, every day consume 50% of your daily energy as liquid supplements, and eat eggs, chicken, potatoes, apple, and bananas daily. Plus, eat unlimited rice, rice noodles and limited amounts of some fruit and vegetables
Phase 2: Follow for 6 weeks, every day consume 25% of your daily energy as liquid supplements and eat eggs, chicken, potatoes, apple, bananas. Plus, eat unlimited rice, rice noodles, start introducing some additional grains, fruits, and vegetables not allowed during phase 1.


Exclusive Enteral Nutrition
EEN is a complete liquid diet, in which patients only consume commercial oral nutrition supplements (nil other foods or beverages permitted).

The amount of EEN recommended to participants will be based on individual energy requirements, calculated using the Scofield equation. Supplements will be provided to patients through the Home Enteral Nutrition (HEN) scheme.


The participants will be commenced on the chosen therapeutic diet for an initial 6 week period, after which they will be assessed for response. If the response criteria are met, they will complete a further 6 weeks on the same therapeutic diet they were previously following (for a total of 12 weeks on the therapeutic diet), and then transition to the maintenance phase - the Step 1: Additive free, Wholefood ‘Mediterranean-style diet’.

If the response criteria are NOT met at 6 weeks, they will be escalated to the next more intensive diet, and then reassessed for response at 6 weeks. If the response criteria are then met after the next 6 week period (on the second intensified diet), they will complete a further 6 weeks on the therapeutic diet (for a total of 12 weeks on the therapeutic diet), and then transition to the maintenance phase - the Step 1: Additive free, Wholefood ‘Mediterranean-style diet’.

Adherence will be monitored using 24-hr diet recalls, a modified medication adherence scale, and the CDED adherence scale.
Intervention code [1] 330884 0
Lifestyle
Comparator / control treatment
There is no control group. Participants will potentially follow more than one diet and thus act as their own controls. Within-participant comparisons will be made for all patients based on the number of dietary interventions required, including for those participants who do not progress to step 2 (i.e., no intensification required).
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341195 0
Biochemical response (faecal calprotectin decrease of more than or equal to 50% from baseline or to less than or equal to 100ug/L OR CRP decrease by more than or equal to 50% or reaching normal level)
Timepoint [1] 341195 0
Week 12 post-intervention commencement
Secondary outcome [1] 446730 0
Disease activity
Timepoint [1] 446730 0
Week 6 post-intervention commencement Week 12 post-intervention commencement
Secondary outcome [2] 446731 0
CDAI decrease of more than or equal to 100 or reaching less than or equal to 150
Timepoint [2] 446731 0
Week 6 post-intervention commencement Week 12 post-intervention commencement
Secondary outcome [3] 446732 0
Change in drug therapy (i.e. withdrawal from study due to ‘treatment failure’)
Timepoint [3] 446732 0
Anytime upto week 52 post-intervention commencement; assessed at Week 1, Week 6, Week 12, Week 18, Week 24 and Week 52 during dietitians consults
Secondary outcome [4] 446733 0
Number of dietary intensifications (step-ups) required to obtain clinical remission
Timepoint [4] 446733 0
24 weeks post-intervention commencement
Secondary outcome [5] 446734 0
Faecal microbiome diversity
Timepoint [5] 446734 0
Week 6, 12, 18, 24 post-intervention commencement
Secondary outcome [6] 446735 0
Dietary Additive intake
Timepoint [6] 446735 0
Week 6, Week 12, Week 18, Week 24 post-intervention commencement
Secondary outcome [7] 446736 0
Diet Satisfaction
Timepoint [7] 446736 0
Week 6, Week 12, Week 18, Week 24 post-intervention commencement
Secondary outcome [8] 446737 0
Energy Intake
Timepoint [8] 446737 0
Week 6, Week 12, Week 18, Week 24 post-intervention commencement
Secondary outcome [9] 446738 0
Patient-rated adherence
Timepoint [9] 446738 0
Week 6, Week 12, Week 18, Week 24 post-intervention commencement
Secondary outcome [10] 446739 0
Dietitian rated adherance
Timepoint [10] 446739 0
Week 6, Week 12, Week 18, Week 24 post-intervention commencement
Secondary outcome [11] 446740 0
Quality of Life
Timepoint [11] 446740 0
Week 6, Week 12, Week 18, Week 24 post-intervention commencement
Secondary outcome [12] 446741 0
Depression and Anxiety (composite measure)
Timepoint [12] 446741 0
Week 6, Week 12, Week 18, Week 24 post-intervention commencement
Secondary outcome [13] 447085 0
Nutrient Intake
Timepoint [13] 447085 0
Week 6, Week 12, Week 18, Week 24 post-intervention commencement
Secondary outcome [14] 447086 0
Proportion of Energy Consumed as Discretionary Foods
Timepoint [14] 447086 0
Week 6, Week 12, Week 18, Week 24 post-intervention commencement

Eligibility
Key inclusion criteria
Adult patients aged 18 years and over with an established diagnosis of Crohn’s disease AND active disease defined as one or more of the following:
o Elevated Faecal Calprotectin (more than or equal to 100 ug/L)
o Elevated C-Reactive Protein (above laboratory reference range)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Gastrointestinal infection within the last 2 weeks including Clostridium difficile
• Commencement or dose increase in the following medications:
o 5-ASA within 2 weeks
o Thiopurines or biologics within 8 weeks
o Janus kinase (JAK) inhibitors within 4 weeks
o Steroid dose >15 mg per day or steroid change within 1 week
• Acute bowel obstruction requiring urgent surgical intervention
• Suspected perforation of the gastrointestinal tract
• Inability to give informed consent
• Inability to understand or follow dietary guidelines
• Diagnosis of DSM-defined eating disorder

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Step-up, treat to target
Patients will be monitored 6-weekly via diet consult, CDAI and faecal calprotectin and CRP.

If adequate improvement in markers of inflammation and symptoms as defined below has not been achieved after a six-weeks, patients will be ‘stepped-up’ to a more restrictive dietary approach.

The assessment criteria for step up to the next phase diet at each 6 weekly visit is FAILURE to meet the following definition of response (primary endpoint criteria): Biochemical response (faecal calprotectin decrease of more than or equal to 50% from baseline or to less than or equal to 100ug/L OR CRP decrease by more than or equal to 50% or to normal level)

If adequate improvement in inflammation and symptoms has been achieved at the 6-weekly diet consult, the patient will remain on the therapeutic diet for a further 6 weeks until a total of 12 weeks has been completed.

Once a response has been achieved and 12 weeks of therapeutic diet completed, patients will be instructed on how to revert to a maintenance dietary therapy (Step 1: Additive free, Wholefood ‘Mediterranean-style diet’).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Logistic regression will be applied to ascertain the impact of age, gender, disease location, time since disease diagnosis, age at disease diagnosis, IL-6 risk phenotype, Adiponectin (ADIPOQ) risk phenotype, beta-diversity, and use of biologics at entry on the likelihood of achieving clinical or biochemical remission during the program (i.e. response versus non-response at final diet step). First, univariate analysis will be undertaken to assess whether there is a significant relationship between the predictor variable and clinical or biochemical response. Significant (P < 0.05) variables will then be included in a multivariate model in a stepwise manner.

Ordinal logistic regression will be applied to ascertain the impact of age, gender, disease location, time since disease diagnosis, age at disease diagnosis, IL-6 risk phenotype, ADIPOQ risk phenotype, beta-diversity, and use of biologics at entry on likelihood of patients need a ‘stricter’ dietary approach. In this model, the outcome categories will be: Clinical/biochemical remission achieved on step 1 (no diterary intensification needed); Clinical/biochemical remission achieved on step 2; Clinical/biochemical remission achieved on step 3; Clinical/biochemical remission achieved on step 4; Clinical/biochemical remission not achieved; Clinical remission achieved but rapid escalation to next dietary step required. First, univariate analysis will be undertaken to assess whether there is a significant relationship between the predictor variables and each ordinal ‘response’ category. Significant (P < 0.05) variables will then be included in a multivariate model in a stepwise manner.

Depending on the distribution of patients who succeeded in each dietary arm, multinomial logistic regression may be applied to ascertain the impact of age, gender, disease location, time since disease diagnosis, age at disease diagnosis, IL-6 risk phenotype, ADIPOQ risk phenotype, beta-diversity, and use of biologics at entry on likelihood of patients response to each dietary approach (wholefood diet, CDED phase 2, CDED phase 1, EEN). First, univariate analysis will be undertaken to assess whether there is a significant relationship between the predictor variables and each ordinal ‘response’ category. Significant (P < 0.05) variables will then be included in a multivariate model in a stepwise manner.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
29/01/2025
Date of last participant enrolment
Anticipated
30/06/2026
Actual
Date of last data collection
Anticipated
30/06/2036
Actual
Sample size
Target
100
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318757 0
Charities/Societies/Foundations
Name [1] 318757 0
This study is being supported by the Australian Gastro Intestinal Research Foundation (AGIRF)
Country [1] 318757 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital
Address
Country
Australia
Secondary sponsor category [1] 321236 0
None
Name [1] 321236 0
Address [1] 321236 0
Country [1] 321236 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317371 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 317371 0
Ethics committee country [1] 317371 0
Australia
Date submitted for ethics approval [1] 317371 0
10/01/2024
Approval date [1] 317371 0
05/03/2024
Ethics approval number [1] 317371 0
DELECTABLE 2.0, 303/23

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

Contacts
Principal investigator
Name 140842 0
Prof Michael A Kamm
Address 140842 0
St Vincents Hospital, 55 Victoria Parade, Fitzroy, Melbourne, 3065
Country 140842 0
Australia
Phone 140842 0
+61 3 9417 5064
Fax 140842 0
Email 140842 0
[email protected]
Contact person for public queries
Name 140843 0
Michael A Kamm
Address 140843 0
55 Victoria Parade, Fitzroy, Melbourne, 3065
Country 140843 0
Australia
Phone 140843 0
+61 3 9417 5064
Fax 140843 0
Email 140843 0
[email protected]
Contact person for scientific queries
Name 140844 0
Gina Trakman
Address 140844 0
St Vincent's Hospital, 55 Victoria Parade, Fitzroy, Melbourne, Victoria, 3065
Country 140844 0
Australia
Phone 140844 0
+61 4 94795655
Fax 140844 0
Email 140844 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Sensitive health data



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.