Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001568808
Ethics application status
Approved
Date submitted
26/07/2021
Date registered
18/11/2021
Date last updated
20/10/2022
Date data sharing statement initially provided
18/11/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Examining diet As Therapy in Ulcerative Colitis (EAT-UC trial)
Scientific title
Examining diet As Therapy in Ulcerative Colitis: a randomised placebo controlled dietary advice trial in adults with mild-moderately active ulcerative colitis (EAT-UC RCT)
Secondary ID [1] 304873 0
nil known
Universal Trial Number (UTN)
Trial acronym
EAT-UC RCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative colitis 322991 0
Condition category
Condition code
Oral and Gastrointestinal 320559 320559 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Therapeutic dietary advice followed for a period of 8 weeks - intervention diet and and placebo control sham diet.
Participants will receive a diet manual detailing the dietary prescription and accompanying food tables of foods to include and avoid, a 1-week set meal plan and an accompanying recipe book during a baseline dietary counselling with a research dietitian.
A selection of staple and non-staple food items will be provided and participants will receive a $400 financial contribution towards shopping bills.
A research dietitian will deliver 30-minutes of face to face dietary counselling.
This will be provided face to face and phone support.
This will occur at baseline, provide dietary support by phone at start of week 2 after transitioning off set meal plan, and 15 minutes of face to face dietary support at week 4 and 8.
Face to face appointments will occur at the hospital.
Dietary adherence will be monitored by self-reported pre-defined compliance categories and completion of 7-day weighed food diaries at weeks 0, 4, 8.
The dietary intervention will be individualised to personal preference within the parameters of each dietary prescription during baseline dietary education, based on week 0 food diary information e.g. if a participant prefers soy milk to cows milk, this can be switched.
Intervention code [1] 321265 0
Treatment: Other
Comparator / control treatment
Placebo control sham dietary advice will be delivered in the same methodology and approach to the intervention dietary advice
Participants will receive a diet manual detailing the dietary prescription and accompanying food tables of foods to include and avoid, a 1-week set meal plan and an accompanying recipe book during a baseline dietary counselling with a research dietitian.
A selection of staple and non-staple food items will be provided and participants will receive a $400 financial contribution towards shopping bills.
A research dietitian will deliver 30-minutes of face to face dietary counselling.
This will be provided face to face and phone support.
This will occur at baseline, provide dietary support by phone at start of week 2 after transitioning off set meal plan, and 15 minutes of face to face dietary support at week 4 and 8.
Face to face appointments will occur at the hospital.
Dietary adherence will be monitored by self-reported pre-defined compliance categories and completion of 7-day weighed food diaries at weeks 0, 4, 8.
The dietary intervention will be individualised to personal preference within the parameters of each dietary prescription during baseline dietary education, based on week 0 food diary information e.g. if a participant prefers soy milk to cows milk, this can be switched.
The placebo control diet will appear very similar to the intervention diet, delivered over the same 8-week time frame, however the placebo control dietary prescription is designed to be inert.
Control group
Placebo

Outcomes
Primary outcome [1] 328382 0
A composite primary outcome of clinical and endoscopic response: a change in UC disease activity between 0 and 8 weeks as defined by a reduction in total Mayo score greater than or equal to 3 points with a reduction in Mayo endoscopic sub score greater than or equal to 1.
Timepoint [1] 328382 0
Week 8 post initiation of diet therapy
Secondary outcome [1] 398821 0
Biomarker response/remission: response defined as absolute change in faecal calprotectin; remission defined as faecal calprotectin <100ug) as measured from stool at weeks 0, 4 and 8
Timepoint [1] 398821 0
Week 8 post initiation of diet therapy
Secondary outcome [2] 398822 0
Histological response: a change in Robarts score between weeks 0 and 8 as per assessment of colonic mucosal tissue biopsies taken during baseline and week 8 flexible sigmoidoscopy procedure
Timepoint [2] 398822 0
Week 8 post initiation of diet therapy
Secondary outcome [3] 398823 0
Dietary adherence to the prescribed dietary principles using predefined compliance categories at weeks 1, 4 and 8 (<25% never/rarely, 25-50% sometimes, 51-75% frequently, 76-100% always) and change in nutritional intake as measured using 7-day weighed food diaries. Predefined compliance categories as used in other landmark gastrointestinal diet therapy studies developed by our collaborative research group.
Timepoint [3] 398823 0
Week 1, 4 and 8 post initiation of diet therapy
Secondary outcome [4] 398824 0
Tolerability of the prescribed diets measured using 100mm VAS (0 extremely intolerable and 100 extremely tolerable where tolerability is defined as mean/median tolerability score greater than or equal to 51)
Timepoint [4] 398824 0
Week 4 and 8 post initiation of diet therapy
Secondary outcome [5] 398834 0
A composite secondary outcome of clinical and endoscopic remission: defined by total Mayo score less than or equal to 2 and no score >1; SCCAI/partial Mayo less than or equal to 1; and induction of endoscopic remission defined by Mayo endoscopic sub-score of 0/UCEIS less than or equal to 1

Timepoint [5] 398834 0
Week 8 post initiation of diet therapy
Secondary outcome [6] 402324 0
Quality of life: median change in food-related quality of life measured using IBD-FRQoL-29 questionnaire
Timepoint [6] 402324 0
Week 8 post initiation of diet therapy
Secondary outcome [7] 402325 0
Safety: safety of the prescribed diets measured by withdrawal from study and records of any adverse events
Timepoint [7] 402325 0
Week 8 post initiation of diet therapy
Secondary outcome [8] 402326 0
Metabolomics: exploratory changes in biomarkers of colonic fermentation measured using a gas-sensing capsule, stool sampling to measure faecal volatile gas production, faecal metabolite production (nitric oxide, sulphide, ammonia, short and branched chain fatty acid production) between weeks 0 and 8
Timepoint [8] 402326 0
Week 8 post initiation of diet therapy
Secondary outcome [9] 402327 0
Metagenomics: exploratory change in colonic microbial constitution composition, and/or diversity and /or function between week 0 and 8 using shotgun metagenomic sequencing
Timepoint [9] 402327 0
Week 8 post initiation of diet therapy
Secondary outcome [10] 402328 0
Mental health: median change in depression, anxiety, stress scores using DASS-21 between weeks 0 and 8
Timepoint [10] 402328 0
Week 8 post initiation of diet therapy
Secondary outcome [11] 402329 0
Fatigue: median change in fatigue severity measured using FACIT-F between weeks 0 and 8
Timepoint [11] 402329 0
Week 8 post initiation of diet therapy
Secondary outcome [12] 403132 0
Biomarker response/remission: response defined as absolute change in C-reactive protein; remission defined as normalisation of C-reactive protein as measured from stool and blood sampling at weeks 0, 4 and 8
Timepoint [12] 403132 0
Week 8 post initiation of diet therapy

Eligibility
Key inclusion criteria
Greater than or equal to 18 years of age with a formal diagnosis of UC
Mild-moderate UC disease activity as defined by a Total Mayo Score of 3-10 with a Mayo endoscopic sub-score of 1 or 2.
Participants on stable therapy (or no therapy) for defined periods of time
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Quiescent UC disease activity as defined by a Total Mayo Score of less than or equal to 2 and/or a Mayo endoscopic sub-score of 0.
Severely active UC as defined by a Total Mayo Score of greater than 10 and/or a Mayo endoscopic sub-score of 3 and/or evidence of systemic toxicity (tachycardia, fever, C-reactive protein greater than 40, Haemoglobin less than 110g/l).
Pregnant
Prior colonic surgery
Crohn's colitis or indeterminate colitis
Corticosteroid therapy (greater than or equal to 20mg oral corticosteroids or any dose IV corticosteroids)
People who habitually follow a vegan or lacto-vegetarian diet
Coeliac disease

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computer generated sequence
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
All study personnel will be blinded except research dietitian delivering dietary education
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Pilot study data was used to inform a power calculation for this study. The sample size required is n=26 participants per group, 52 participants in total. Comparison of end-points between dietary groups will be performed. Changes in clinical symptoms and disease activity will be correlated with metagenomic markers. The primary analysis will be an intention-to-treat (ITT) analysis with a secondary per protocol analysis. Last recorded values will be carried forward in the ITT analysis where a protocol breach or drop out may occur. The statistical analysis will include linear mixed effects models with adjustment for confounding factors.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
22/11/2021
Actual
22/10/2021
Date of last participant enrolment
Anticipated
22/12/2023
Actual
Date of last data collection
Anticipated
1/03/2024
Actual
Sample size
Target
52
Accrual to date
11
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 20082 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 34790 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 309247 0
Charities/Societies/Foundations
Name [1] 309247 0
The Hospital Research Foundation
Country [1] 309247 0
Australia
Funding source category [2] 312489 0
Charities/Societies/Foundations
Name [2] 312489 0
Gutsy Group
Country [2] 312489 0
Australia
Funding source category [3] 312490 0
Charities/Societies/Foundations
Name [3] 312490 0
European Crohn's Colitis Organisation
Country [3] 312490 0
Austria
Primary sponsor type
Government body
Name
Central Adelaide Local Health Network
Address
28 Woodville Road, Woodville South, South Australia 5011
Country
Australia
Secondary sponsor category [1] 310216 0
None
Name [1] 310216 0
Address [1] 310216 0
Country [1] 310216 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309092 0
Central Adelaide Local Health Network Human Research ethics Committee
Ethics committee address [1] 309092 0
Royal Adelaide Hospital
1 Port Road, Adelaide 5000
South Australia
Ethics committee country [1] 309092 0
Australia
Date submitted for ethics approval [1] 309092 0
10/06/2020
Approval date [1] 309092 0
15/10/2020
Ethics approval number [1] 309092 0
13449

Summary
Brief summary
Diet has potential to bridge the therapeutic gap in ulcerative colitis (UC). The proposed study evaluates a therapeutic diet for patients with mild-moderately UC. This diet will be tested in an 8-week randomised, placebo-controlled dietary advice study. Patients with mild-moderately active UC on stable therapy will be eligible for inclusion. Those eligible will be invited to provide informed consent then undertake baseline measurements including a 48-h stool collection, blood and urine sampling, clinical questionnaires, 7-day weighed food diary and a flexible sigmoidoscopy to confirm presence of inflammation. Participants will then be enrolled and undergo ingestion of a gas-sensing capsule before being randomised and blinded to receive one of two diets from a research dietitian. Meal plans and recipes will be provided along with a selection of food items. Participants will be reviewed at weeks 4 and 8, with repeating of baseline assessments at week 8.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112946 0
Mrs Alice Day
Address 112946 0
The Queen Elizabeth Hospital
Department of Gastroenterology
28 Woodville Road
Woodville South
South Australia 5011
Country 112946 0
Australia
Phone 112946 0
+61 8 8222 8984
Fax 112946 0
Email 112946 0
Alice.Day@sa.gov.au
Contact person for public queries
Name 112947 0
Mrs Alice Day
Address 112947 0
The Queen Elizabeth Hospital
Department of Gastroenterology
28 Woodville Road
Woodville South
South Australia 5011
Country 112947 0
Australia
Phone 112947 0
+61 8 822268984
Fax 112947 0
Email 112947 0
Alice.Day@sa.gov.au
Contact person for scientific queries
Name 112948 0
Dr Robert Bryant
Address 112948 0
The Queen Elizabeth Hospital
Department of Gastroenterology
28 Woodville Road
Woodville South
South Australia 5011
Country 112948 0
Australia
Phone 112948 0
+61 8 8222 68984
Fax 112948 0
Email 112948 0
Robert.Bryant@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data underlying published results
When will data be available (start and end dates)?
Available from December 2023 to December 2028
Available to whom?
Researchers who provide a methodologically sound proposal
Available for what types of analyses?
Meta-analyses, systematic reviews
How or where can data be obtained?
Contact principal investigator via email Robert.Bryant@sa.gov.au
Subject to approval by principle investigator


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.