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Trial registered on ANZCTR


Registration number
ACTRN12621001708842
Ethics application status
Approved
Date submitted
31/08/2021
Date registered
13/12/2021
Date last updated
13/12/2021
Date data sharing statement initially provided
13/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of a diet low in fats, additives and wheat on maintenance of remission in adults with Crohn's disease
Scientific title
Effect of a diet low in fats, additives and wheat on maintenance of remission in adults with Crohn's disease
Secondary ID [1] 305183 0
None
Universal Trial Number (UTN)
Trial acronym
FEW diet trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's disease 323456 0
Condition category
Condition code
Inflammatory and Immune System 321006 321006 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants identified from the digestive health biobank who meet the inclusion criteria will be invited to enter the dietary trial. We will evaluate, in a proof-of-concept trial, whether exclusion of foods containing excess animal fats, emulsifiers and wheat (FEW), which are commonly reported as triggers in Crohn's disease is efficacious in maintaining remission in patients. The study design will be a randomised controlled trial of the FEW foods exclusion diet compared to standard inflammatory bowel disease dietary management. The primary outcome for this study is the maintenance of remission (time to flare in days).
Participants randomised to FEW diet or standard care diet, with initial 1 hour dietitian consult and monthly 30 minute review (face-to-face or telehealth). The dietitian is the interventionist and will report time in remission and time to flare over 6 months.
A daily food checklist and once weekly automated 24 hour recall will be used to monitor adherence to the intervention. If the intervention is effective in maintaining remission for significantly longer than control die, the control group will be offered to cross over to intervention for the following 6 months (without washout period). Intervention group can continue with FEW diet but will not receive further dietetic follow up.
Intervention code [1] 321581 0
Treatment: Other
Comparator / control treatment
Standard dietetic management of Crohn's disease (healthy eating, nutritional adequacy, fibre modulated, anti-inflammatory diet)
Control group
Active

Outcomes
Primary outcome [1] 328786 0
Time to IBD flare (days) as assessed via study-specific questionnaire.
Timepoint [1] 328786 0
Time in days, followed for a maximum of 12 months post-commencement of diet.
Secondary outcome [1] 400341 0
Faecal calprotectin (ug/ml)
Timepoint [1] 400341 0
Monthly for six months, then at 12 months post-commencement of diet,
Secondary outcome [2] 400342 0
Short Inflammatory Bowel Disease Questionnaire (SIBDQ) score
Timepoint [2] 400342 0
Every three months for 12 months post-commencement of diet
Secondary outcome [3] 401021 0
Dietary compliance to fats, emulsifiers and wheat diet, (number of FEW food items per day/week)
Timepoint [3] 401021 0
Assessed monthly using food frequency questionnaire , calculated as mean (SD) per day
Secondary outcome [4] 401022 0
Metagenomic sequencing of mucosal associated micorbiome and stool microbiome. Anslysis of diversity and abundance, and functional characteristics.
Timepoint [4] 401022 0
0 and 12 months (mucosal)
Monthly (stool)

Eligibility
Key inclusion criteria
1. Adults aged 18 to 50 years
2. Males and females
3. Crohn’s disease; a new diagnosis (within the last 2 years) of mild to moderate ileal or ileo-colonic disease (Crohn’s Disease Activity Index (CDAI) 150 – 450) and faecal calprotectin (FC)
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnancy
2. Post-resection surgery
3. Smokers
4. BMI greater than or equal to 30
5. Other autoimmune or atopic conditions
6. Other dietary restrictions or modifications that would prevent individual from completing dietary intervention (e.g., coeliac disease)
7. Unable to complete the study participation requirements

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 concealed by central randomisation by computer, conducted by research assistant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Study participants will be randomised into age (5 or 10-year age bracket) and sex-matched standard care control and intervention arms. Randomisation will be stratified to address the need to control for covariates. This method will be used to achieve balance among groups in terms of participants’ baseline characteristics. Specific covariates that may influence study outcomes include medication regime, time since diagnosis, disease severity. A separate block will be created for each combination of covariates, and participants will be assigned to the appropriate block of covariates.
After all participants have been assigned into blocks, simple computer-generated randomisation will be performed within each block.
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
Efficacy
Statistical methods / analysis
Datasets will be analysed and graphed using GraphPad Prism 8 software version 8.1 (GraphPad Software Inc., La Jolla, USA). Comparators are pre- versus post- samples for the CD patients in the dietary trial. Data will be analysed for normality of distribution using the D'Agostino & Pearson test, where p<0.05 indicates data that is not normally distributed. The mean demographic characteristics of the CD patients pre- versus post- samples for CD patients in the dietary trial (Study 2) will be analysed by parametric t tests where the data is normally distributed and by the equivalent non parametric t test where the distribution is not normal. This cohort data will be presented as mean standard deviation (SD) and p<0.05 will be considered significant. Fisher’s exact test will be used to analyse potential effects of co-morbidities and confounders between the comparators Relationships between the presence or absence of a sero-reactive response between the comparators will be analysed by Chi-square testing and p<0.05 will be considered significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/02/2022
Actual
Date of last participant enrolment
Anticipated
1/08/2022
Actual
Date of last data collection
Anticipated
1/08/2023
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 20437 0
John Hunter Hospital - New Lambton
Recruitment postcode(s) [1] 35203 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 309566 0
Charities/Societies/Foundations
Name [1] 309566 0
Hunter Medical Research Institute donor funding
Country [1] 309566 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Centre of Research Excellence in Digestive Health
Address
Kookaburra Circuit, New Lambton Heights 2305 NSW
Country
Australia
Secondary sponsor category [1] 310573 0
None
Name [1] 310573 0
Address [1] 310573 0
Country [1] 310573 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309345 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 309345 0
Hunter Medical Research institute, New Lambton Heights 2305 NSW
Ethics committee country [1] 309345 0
Australia
Date submitted for ethics approval [1] 309345 0
31/08/2021
Approval date [1] 309345 0
12/10/2021
Ethics approval number [1] 309345 0

Summary
Brief summary
We will evaluate, in a proof-of-concept trial, whether exclusion of FEW-containing foods which are commonly reported as triggers in CD is efficacious in maintaining remission in patients. The study design will be a randomised controlled trial of the FEW foods exclusion diet compared to standard IBD dietary management. The primary outcome for this study is the maintenance of remission (time to flare in days). We predict that the diet low in fats, emulsifiers and wheat will maintain IBD remission for longer than the standard care diet.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113846 0
Prof Nicholas Talley
Address 113846 0
Hunter Medical Research Institute, New Lambton Heights 2305 NSW
Country 113846 0
Australia
Phone 113846 0
+61 2 40420491
Fax 113846 0
Email 113846 0
[email protected]
Contact person for public queries
Name 113847 0
Kerith Duncanson
Address 113847 0
Hunter Medical Research Institute, New Lambton Heights 2305 NSW
Country 113847 0
Australia
Phone 113847 0
+61428848264
Fax 113847 0
Email 113847 0
[email protected]
Contact person for scientific queries
Name 113848 0
Kerith Duncanson
Address 113848 0
Hunter Medical Research Institute, New Lambton Heights 2305 NSW
Country 113848 0
Australia
Phone 113848 0
+61428848264
Fax 113848 0
Email 113848 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Dietary intake (food, nutrient)
Microbiome (16s, MGS)
When will data be available (start and end dates)?
August 2022 to August 2037
Available to whom?
Researchers
Available for what types of analyses?
Secondary anallysis, deidentified
How or where can data be obtained?
Principal investigator [email protected] by request and https://digestivehealth.org.au/


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13032Study protocol    382697-(Uploaded-31-08-2021-05-17-22)-Study-related document.docx



Results publications and other study-related documents

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