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Trial registered on ANZCTR


Registration number
ACTRN12619000063112
Ethics application status
Approved
Date submitted
2/11/2018
Date registered
17/01/2019
Date last updated
17/01/2019
Date data sharing statement initially provided
17/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Exploring adjuvant therapy in Ulcerative Colitis
Scientific title
Exploring the tolerability of an adjuvant dietary therapy in Ulcerative Colitis
Secondary ID [1] 296428 0
Nil known
Universal Trial Number (UTN)
Trial acronym
EAT-UC
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 310186 0
Condition category
Condition code
Oral and Gastrointestinal 308934 308934 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
8-week dietary advice trial where a nutritionally balanced dietary intervention is prescribed through verbal and written instruction by a Dietitian at the start of the 8 week intervention with follow up and dietary support available throughout the trial and during reviews at the end of week 1 and 4. The diet is an adjuvant therapy for people with mild-moderate Ulcerative Colitis, delivered in an outpatient setting. Dietary advice to be provided includes practical strategies to nutritionally balance diet, reduce preservatives, and modify fermentable fibres.
Intervention code [1] 312756 0
Treatment: Other
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307896 0
Tolerability of prescribed dietary strategy as measured by 100mm visual analogue scales
Timepoint [1] 307896 0
8 weeks post commencing the prescribed diet
Secondary outcome [1] 353258 0
Adherence to the prescribed diet using 3-day weighted food diaries and dietary adherence checklists
Timepoint [1] 353258 0
4 and 8 weeks post commencing prescribed diet
Secondary outcome [2] 353259 0
Clinical response - change in Ulcerative Colitis disease activity as defined by a change in Mayo score >= 3 points
Timepoint [2] 353259 0
8 weeks post commencing prescribed diet
Secondary outcome [3] 353260 0
Endoscopic response - change in ulcerative colitis disease activity as defined by a change in Mayo endoscopic sub-score >/= 1 point
Timepoint [3] 353260 0
8 weeks post commencing prescribed diet
Secondary outcome [4] 353261 0
Change in the colonic microbial composition, diversity and function using molecular methods and assessing short chain fatty acids and phenols
Timepoint [4] 353261 0
4 and 8 weeks post commencing prescribed diet
Secondary outcome [5] 353262 0
Change in Food-related quality of life (FRQoL) as defined by validated FRQoL questionnaire
Timepoint [5] 353262 0
8 weeks post commencing prescribed diet
Secondary outcome [6] 353596 0
Nutritional adequacy of prescribed diet using 3-day weighed food diaries and Foodworks9 dietary analysis software
Timepoint [6] 353596 0
4 and 8 weeks post commencing prescribed diet

Eligibility
Key inclusion criteria
Greater than or equal to 18 years of age with a formal diagnosis of ulcerative colitis
Mild-moderate ulcerative colitis disease activity as defined by a Mayo Score of 3-10 with a Mayo endoscopic sub-score of greater than or equal to 1
Patients on stable therapy (or no therapy) for defined periods:
No therapy for greater than or equal to 4 weeks
Stable dose of oral and/or topical 5-aminosalicylic acid therapy for greater than or equal to 4 weeks
Stable dose of immunomodulator therapy (azathioprine, mercaptopurine, or methotrexate) for greater than or equal to 8 weeks
Stable dose of biologic therapy (infliximab, adalimumab, vedolizumab) for greater than or equal to 12 weeks
Steroid refractory – on <20mg corticosteroids for greater than or equal to 4 weeks
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Quiescent ulcerative colitis disease activity as defined by a 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 Mayo Score of greater than 10 and/or evidence of systemic toxicity (tachycardia, fever, C-reactive protein >40, Haemoglobin <110g/l).
Patients with Crohn’s colitis
Patients who are pregnant or breast feeding
Patients with significant medical or cognitive/psychiatric comorbidities
Patients who have undergone prior colonic surgery
People currently receiving tapering corticosteroid therapy
People with evidence of active infection and/or those requiring current antibiotic therapy
People receiving dual antiplatelet therapy or anticoagulant therapy
People who are unable to provide informed consent

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)
Allocation not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to describe subject baseline characteristics as well as tolerability of the diet over the study period. Linear mixed effects models will be used to assess changes within the group over time. Adjusted analysis will be performed if there are over confounding factors evident.

The sample size for the dietary intervention study was calculated using an a priori power calculation. Given that this is a pilot study, and preliminary data for the dietary intervention does not exist, the estimated tolerability of a medication used to induce remission of active UC was used as a substitute. The study is powered to detect a significant difference in the primary outcome following dietary intervention with 15 patients enrolled the pilot study (alpha=0.05, 80% power).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 12262 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [2] 12263 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 24451 0
5011 - Woodville
Recruitment postcode(s) [2] 24452 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 301029 0
University
Name [1] 301029 0
University of Adelaide
Address [1] 301029 0
North Terrace
Adelaide 5000
South Australia
Country [1] 301029 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
North Terrace
Adelaide 5000
South Australia
Country
Australia
Secondary sponsor category [1] 300696 0
None
Name [1] 300696 0
Address [1] 300696 0
Country [1] 300696 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301782 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 301782 0
Level 3
Roma Mitchell House
North Terrace
Adelaide
5000
South Australia
Ethics committee country [1] 301782 0
Australia
Date submitted for ethics approval [1] 301782 0
Approval date [1] 301782 0
29/03/2016
Ethics approval number [1] 301782 0
HREC/16/RAH/24

Summary
Brief summary
This is a pilot dietary intervention study involving an 8-week dietary intervention prescribed in addition to standard therapy for patients with mild-moderately active ulcerative colitis. People who meet the inclusion criteria and who provide informed consent will be provided with a Dietitian administered meal plan for the study period. Tolerance of and adherence to the prescribed diet will be assessed, along with the nutritional adequacy of the diet. The impact of the diet on luminal intestinal inflammation will be assessed, as well as its effect on the gut microbiome.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 88090 0
Mrs Alice Day
Address 88090 0
Department of Gastroenterology
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South
5011
South Australia
Country 88090 0
Australia
Phone 88090 0
+61 413550112
Fax 88090 0
Email 88090 0
Alice.Day@sa.gov.au
Contact person for public queries
Name 88091 0
Mrs Alice Day
Address 88091 0
Department of Gastroenterology
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South
5011
South Australia
Country 88091 0
Australia
Phone 88091 0
+61 413550112
Fax 88091 0
Email 88091 0
Alice.Day@sa.gov.au
Contact person for scientific queries
Name 88092 0
Mrs Alice Day
Address 88092 0
Department of Gastroenterology
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South
5011
South Australia
Country 88092 0
Australia
Phone 88092 0
+61 413550112
Fax 88092 0
Email 88092 0
Alice.Day@sa.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
Pending study outcomes for consideration of peer reviewed publication
What supporting documents are/will be available?
No other documents available
Summary results
No Results