Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001289606p
Ethics application status
Submitted, not yet approved
Date submitted
15/11/2022
Date registered
11/12/2023
Date last updated
11/12/2023
Date data sharing statement initially provided
11/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Determining the feasibility of the use of the Crohn’s Disease Exclusion Diet (CDED) in adults with Crohn’s disease: A Pilot Study
Scientific title
Determining the feasibility of the use of the Crohn’s Disease Exclusion Diet (CDED) in adults with Crohn’s disease: A Pilot Study
Secondary ID [1] 308422 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohns disease 328223 0
Condition category
Condition code
Inflammatory and Immune System 325272 325272 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 327060 327060 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Crohns Disease Exclusion Diet (CDED).
In summary the diet involves the consumption of whole foods but reduces exposure to dietary components that have been shown to induce a flare. The whole foods are also combined with partial enteral nutrition (PEN), or drinks that will supplement the macro & micro nutrients missing from the diet. The main food groups excluded are, gluten, wheat, dairy products, some animal fat, processed meats, emulsifiers, canned foods, soft drinks, alcohol & and coffee. With the inclusion of resistant starch and pectin fibres. The CDED involves 3 phases over 12+ weeks.

A dietitian will conduct all education sessions with the participants. They will receive education on all 3 phases of the diet and information pertaining to the PEN. The education will be given to the patient before the commencement of phase 1 - they will be educated on all 3 phases in one sitting. The sessions will take approx. 1hr.
Phase 1 (6 weeks) is 50% CDED mandatory & allowed foods+ 50% Partial Enteral Nutrition (PEN).
Phase 2 (6 weeks) will be commenced and education provided. Phase 2 is 75% CDED mandatory & allowed foods+ 25% Partial Enteral Nutrition (PEN).

The PEN will be provided to the participants free of charge. Nutricia Australia will provide 142 cartons of ‘Fortisip’ (200ml bottles) to the study in four different flavours (vanilla, chocolate, strawberry & banana). The participants will be allowed to taste test each flavour and are able to pick as many flavours as they choose to complete the study. The participants will each be assigned a specific number of ‘Fortisip’ (200ml bottles) that will individually suit their calculated nutrition requirements.
The ‘Fortisip’ supplements (200ml bottles) are nutritionally complete, medical grade oral nutrition supplements that can be consumed as a sole source of nutrition if required.

As per the Nestle Modulife CDED Program & DECCAN Clinical Practice Toolkit8, Phase 3 (Maintenance Phase) has limited evidence related to maintaining a restrictive diet in the long term. The participants will be advised to gradually re-introduce their usual diet. They will be educated on maintaining a healthy, well-balanced diet in line with the Australian Guide to Healthy Eating. The participants will be advised to continue avoiding processed foods including processed meats, soft drink, ultra-processed foods and excessive caffeine and alcohol.

At the end of each review a supplement stocktake will be completed to compare the number of ‘Fortisip’ supplements (200ml bottles) consumed to the volume of supplements the participant should be drinking (i.e. as calculated) to manage reports of over/under reporting.
After weeks 1,2,6,8 &12 of the diet a review will be conducted to assess 24hr recall (i.e. dietary intake), gastrointestinal symptoms using the Gastrointestinal Symptom Scale, and compliance to the diet using the Medication Adherence Rating Scale.

Intervention code [1] 324873 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333129 0
We will assess the feasibility of the CDED in practice for patients with mild-severe Crohns Disease. Primary outcome: to assess the participant’s compliance to the diet.

At the end of each review a supplement stocktake will be completed to compare the number of ‘Fortisip’ supplements (200ml bottles) consumed to the volume of supplements the participant should be drinking (i.e. as calculated) to manage reports of over/under reporting.
After weeks 1,2,6,8 &12 of the diet a review will be conducted to assess compliance to the diet using the 24hr recall (i.e. dietary intake) and the Medication Adherence Rating Scale.
Timepoint [1] 333129 0
After weeks 1,2,6,8 &12
Secondary outcome [1] 415907 0
At the completion of the CDED is there a decrease or normalisation of inflammatory markers including CRP & FCP from baseline to intervention.

Blood tests at weeks 1, 6 & 12 of the intervention to assess changes in CRP & FCP
Timepoint [1] 415907 0
Change after 1, 6 & 12 weeks of the diet
Secondary outcome [2] 422434 0
At the completion of the CDED is there a change in Crohns Disease Activity Index (CDAI)

Conduct CDAI scoring at weeks 1 & 12 of the intervention to assess changes CDAI.
Timepoint [2] 422434 0
After 1 & 12 weeks of the diet
Secondary outcome [3] 422436 0
At the completion of the CDED are there any changes in nutrition impact symptoms, measured using the Gastrointestinal Symptom Rating Scale.

Complete Gastrointestinal Symptom Scale at all reviews weeks 1,2,6,8 & 12.
Timepoint [3] 422436 0
Changes after 1,2,6,8 & 12.
Secondary outcome [4] 422437 0
Change in quality of life score

Measured using IBD-QoL tool
Timepoint [4] 422437 0
At weeks 1 & 12 weeks of the intervention

Eligibility
Key inclusion criteria
• Male or female participant’s 18 years or older with moderate to severe luminal Crohn’s Disease
• Crohns Disease Activity Index (CDAI) greater than or equal to 220
• C Reactive Protein (CRP) greater than or equal to 15 OR Platelets greater than or equal to 450 OR Faecal Calprotectin (FCP) greater than 150
• Patients not excluded if they had received Mesalamine or a stable dose of immunomodulator for greater than 6 weeks
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients without Crohn’s disease, patients with ulcerative colitis and patients with Inflammatory Bowel Disease - Unknown (IBD-U)
• Patients with Crohn’s disease in clinical remission (CDAI score <220)
• Patients < 18 years old
• Patients receiving steroids or who have started an immunomodulator in the previous 6 weeks, current or past biological treatment
• Patients with complicated, extraintestinal or active penetrating perianal disease (abscess or fistula)
• Fixed non-inflammatory stricture or small bowel obstruction
• Normal CRP (<15g) & normal FCP (<150)
• Sclerosing cholangitis
• Pregnancy
• Patients who have been treated by PEN that exceeds 50% of nutritional needs 2 weeks before enrolment
• Positive Clostridium difficile toxin
• Patients who are unable to consent due to language barriers or cognitive function
• Patients who are culturally and linguistically diverse (CALD) or non-english speaking background (NESB)
• Patients who have documented cognitive impairment

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
Who is / are masked / blinded?



Intervention assignment
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
1/01/2024
Actual
Date of last participant enrolment
Anticipated
1/07/2024
Actual
Date of last data collection
Anticipated
2/07/2024
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23572 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 38994 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 312672 0
Commercial sector/Industry
Name [1] 312672 0
Nutricia Australia
Country [1] 312672 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
50 Missenden Rd CamperdownNSW 2050
Country
Australia
Secondary sponsor category [1] 314283 0
Hospital
Name [1] 314283 0
Royal Prince Alfred Hospital
Address [1] 314283 0
50 Missenden Rd CamperdownNSW 2050
Country [1] 314283 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311976 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 311976 0
50 Missenden Rd CamperdownNSW 2050
Ethics committee country [1] 311976 0
Australia
Date submitted for ethics approval [1] 311976 0
21/09/2022
Approval date [1] 311976 0
Ethics approval number [1] 311976 0

Summary
Brief summary
The purpose of this study is to investigate the feasibility and effectiveness of the CDED in adult patients with Crohn’s disease on outcomes including compliance of the diet, changes in nutrition impact symptoms and quality of life; in comparison to their baseline diet.
It is hypothesized that if patients are compliant with the CDED and the CDED is completed appropriately and in its entirety, it will be a feasible treatment strategy and effective in inducing remission for adult patients with Crohn’s Disease.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123030 0
Miss Maddison Breen
Address 123030 0
Royal Prince Alfred Hospital, 50 Missenden Rd CamperdownNSW 2050
Country 123030 0
Australia
Phone 123030 0
+61 295158053
Fax 123030 0
Email 123030 0
Maddison.Breen@health.nsw.gov.au
Contact person for public queries
Name 123031 0
Miss Maddison Breen
Address 123031 0
Royal Prince Alfred Hospital, 50 Missenden Rd CamperdownNSW 2050
Country 123031 0
Australia
Phone 123031 0
+61 295158053
Fax 123031 0
Email 123031 0
Maddison.Breen@health.nsw.gov.au
Contact person for scientific queries
Name 123032 0
Miss Maddison Breen
Address 123032 0
Royal Prince Alfred Hospital, 50 Missenden Rd CamperdownNSW 2050
Country 123032 0
Australia
Phone 123032 0
+61 295158053
Fax 123032 0
Email 123032 0
Maddison.Breen@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.