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Trial registered on ANZCTR


Registration number
ACTRN12619001500145p
Ethics application status
Submitted, not yet approved
Date submitted
30/09/2019
Date registered
30/10/2019
Date last updated
30/10/2019
Date data sharing statement initially provided
30/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects on disease activity, self-reported symptoms and microbiota profile in patients with inflammatory bowel disease of a modified anti-inflammatory diet.
Scientific title
Effects on disease activity, self-reported symptoms and microbiota profile in patients with inflammatory bowel disease of a modified anti-inflammatory diet.
Secondary ID [1] 299448 0
Nill known
Universal Trial Number (UTN)
Trial acronym
IBD MAID
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory Bowel Disease 314647 0
Condition category
Condition code
Diet and Nutrition 312985 312985 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following the completion of screening patients will be randomized to intervention arm or control arm. In the intervention arm patients will receive IBD-MAID (IBD modified anti-inflammatory diet) meals for lunch and dinner and advised on appropriate breakfast and snack options by the dietitian at a 1 hour face to face appointment. All meals provided and breakfast/snack options/recipes will align with IBD MAID guidelines (contain no artificial sweeteners, emulsifiers, cured/processed meats and must combine to meet the daily targets of pro-inflammatory diet constituents such as extra virgin olive oil, fruits, vegetables and wholegrains daily). Participants in the control group will see the dietitian face to face for a 1 hour appointment for general dietary advice (GDA) and be provided with recipes from the eat for health national campaign for the 8 week period. Baseline measures will be repeated at week 8 and participants will have a 1 week washout period before being crossed over to the intervention arm. After the 8 week intervention period all participants will be invited to continue following the IBD MAID diet for a further 10 months. Consenting participants will receive further IBD MAID education and counselling from the dietitian at the 8 week follow up 30-45 minute face to face appointment. Participants will have the contact details of the dietitian for support during the intervention period. The dietitian will also send participants new recipes monthly during the 10 month period and participants will be contacted monthly by the dietitian via telehealth or phone (~10 mins) to provide additional dietary support and guidance. IBD MAID dietary adherence will be assessed by an online 3 day food diary completed monthly and checklist of key dietary nutrients completed weekly.
Intervention code [1] 315693 0
Treatment: Other
Intervention code [2] 315862 0
Lifestyle
Comparator / control treatment
The general healthy eating (GHE) group receives dietitian education and a written resource on general healthy eating with IBD. A booklet of healthy recipes obtained from the ‘Eat for Health,’ national campaign will also be provided.
Control group
Active

Outcomes
Primary outcome [1] 321556 0
Disease activity assessed via the Simple Clinical Colitis Activity Index (SCCAI) score for participants with UC.
Timepoint [1] 321556 0
8 weeks post intervention commencement.
Primary outcome [2] 321819 0
Disease activity assessed via the Crohn’s Disease Activity Index (CDAI) score for participants with CD.
Timepoint [2] 321819 0
8 weeks post intervention commencement
Secondary outcome [1] 375349 0
Dietary intake composition: 3-day diet diary completed online analysed on Foodworks Xyris version 9

Timepoint [1] 375349 0
8 weeks post intervention commencement.
Secondary outcome [2] 375724 0
Inflammatory marker: C-reactive protein (CRP)
Obtained via blood sample.
Timepoint [2] 375724 0
8 weeks post intervention commencement
Secondary outcome [3] 375725 0
Patient reported outcomes (PROs); stool frequency, rectal bleeding and abdominal pain
Assessed on a 5 point likert scale.
Timepoint [3] 375725 0
8 weeks post intervention commencement
Secondary outcome [4] 375726 0
Microbiota profile changes post diet implementation via 16S rRNA gene (a phylogenetics marker present in all bacteria) sequencing.of a stool sample.
Timepoint [4] 375726 0
8 weeks post intervention commencement
Secondary outcome [5] 375727 0
Attrition rates
Timepoint [5] 375727 0
8 weeks post intervention commencement.
Secondary outcome [6] 375728 0
Endoscopic changes indicating mucosal healing assessed via flexible sigmoidoscopy or endoscopy.
Timepoint [6] 375728 0
8 weeks post intervention commencement.
Secondary outcome [7] 375730 0
Percentage of UC patients maintaining clinical improvements in SCCAI after adhering to the IBD modified anti-inflammatory diet for 12 months
Timepoint [7] 375730 0
12 months post intervention commencement
Secondary outcome [8] 376102 0
Inflammatory marker: faecal calprotectin (FC)
Obtained from a stool sample
Timepoint [8] 376102 0
8 weeks post intervention commencement
Secondary outcome [9] 376103 0
IBD Quality of life score (PRO).
Assessed vis the 'Short Inflammatory Bowel Disease Questionnaire'(SIBDQ) is a 10 item shortened version of the
original IBDQ which was 32 items. Measures quality of life as measured in four domains, bowel
symptoms, emotional health, systemic systems and social function.
Timepoint [9] 376103 0
8 weeks post intervention commencement
Secondary outcome [10] 376344 0
Checklist of key dietary ingredients
Timepoint [10] 376344 0
Weekly for 8 weeks post intervention commencement.
Secondary outcome [11] 376345 0
Percentage of CD patients maintaining clinical improvements in CDAI after adhering to the IBD modified anti-inflammatory diet for 12 months
Timepoint [11] 376345 0
12 months post intervention commencement

Eligibility
Key inclusion criteria
Diagnosis of UC or CD established for at least 3 months prior to time of consent
Mild to moderate disease activity at time of consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Become pregnant or are currently pregnant or lactating
- Current smokers or individuals who have ceased smoking within12 months prior to screening
- Excessive ETOH consumption as defined as >2glasses per day
- Multiple food allergies/intolerances which may affect ability to follow the diet prescription.

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)
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
The control group crosses over to the intervention group (participants in the intervention group who consent continue following the IBD MAID diet for a further 10 months i.e. do not cross over to control group).
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet 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)
QLD

Funding & Sponsors
Funding source category [1] 303951 0
University
Name [1] 303951 0
The University of Queensland
Address [1] 303951 0
Human Movement and Nutrition Sciences
Building 26B
St Lucia, Queensland, Australia 4067
Country [1] 303951 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Human Movement and Nutrition Sciences
Building 26B
St Lucia, Queensland, Australia 4067
Country
Australia
Secondary sponsor category [1] 304109 0
None
Name [1] 304109 0
Address [1] 304109 0
Country [1] 304109 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304451 0
Metro North Hospital and Health Service
Ethics committee address [1] 304451 0
Lower ground floor, Executive Offices
James Mayne Building
Butterfield Street
HERSTON QLD 4029
Ethics committee country [1] 304451 0
Australia
Date submitted for ethics approval [1] 304451 0
30/09/2019
Approval date [1] 304451 0
Ethics approval number [1] 304451 0

Summary
Brief summary
The aim of this study is to investigate the safety, feasibility and efficacy of an anti-inflammatory diet prescription to dampening inflammatory pathways, in conjunction with standard medical therapy, on disease activity, and the gut microbiota composition in individuals with mild to moderate disease.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96990 0
Ms Abigail Marsh
Address 96990 0
Department of Nutrition and Dietetics
Royal Brisbane and Women’s Hospital
Butterfield St
Herston, Queensland, Australia 4006
Country 96990 0
Australia
Phone 96990 0
+61 7 36460544
Fax 96990 0
Email 96990 0
Abigail.Marsh@uq.net.au
Contact person for public queries
Name 96991 0
Ms Abigail Marsh
Address 96991 0
Department of Nutrition and Dietetics
Royal Brisbane and Women’s Hospital
Butterfield St
Herston, Queensland, Australia 4006
Country 96991 0
Australia
Phone 96991 0
+61 7 36460544
Fax 96991 0
Email 96991 0
Abigail.Marsh@uq.net.au
Contact person for scientific queries
Name 96992 0
Ms Abigail Marsh
Address 96992 0
Department of Nutrition and Dietetics
Royal Brisbane and Women’s Hospital
Butterfield St
Herston, Queensland, Australia 4006
Country 96992 0
Australia
Phone 96992 0
+61 7 36460544
Fax 96992 0
Email 96992 0
Abigail.Marsh@uq.net.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 other documents available
Summary results
No Results