Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000009516
Ethics application status
Approved
Date submitted
21/11/2023
Date registered
9/01/2024
Date last updated
9/01/2024
Date data sharing statement initially provided
9/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of Exclusive Enteral Nutrition (EEN) with fibre in healthy participants
Scientific title
The impact of Exclusive Enteral Nutrition with fibre on intestinal physiology and microbiology in healthy controls
Secondary ID [1] 311006 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
This is a follow up study from a previously performed study examining EEN (without fibre) in a similar protocol (ACTRN12621000568819)

Health condition
Health condition(s) or problem(s) studied:
Crohn's disease 332113 0
Condition category
Condition code
Inflammatory and Immune System 328840 328840 0 0
Autoimmune diseases
Diet and Nutrition 328841 328841 0 0
Other diet and nutrition disorders
Oral and Gastrointestinal 328842 328842 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exclusive enteral nutrition (EEN) involves the provision of specialised liquid nutrition formula, excluding all table foods and fluids with the exception of water, to patient's with Crohn's Disease to induce remission. In this study we will be giving EEN with fibre (Nutricia, Fortisip Multifibre) to healthy participants for a period of 3 weeks to assess changes this has on intestinal physiology and microbiology. Frequency of administration will be dependent on individual participant's estimated nutrition requirements, however likely to be 5-8 200ml bottles/day (spread across the day based on participant preference). Each 200ml bottle provides 1290kJ, 12g protein, 36.8g carbohydrate, 11.6g fat and 4.4g fibre)
The EEN regime will be prescribed by a dietitian with >10 years experience. Estimated nutrition requirements will be calculated (energy and protein) by the dietitian and amount of formula prescribed will meet these estimated requirements.
All formula will be provided to the participants at no cost.
Participants progress with EEN will be reviewed weekly by the dietitian (face to face or via phone) and adjusted accordingly based on tolerance, weight fluctuations and satiety
Adherence will be assessed by direct questioning, participant maintained diaries and amount of formula used.
Study visits whilst on EEN (to collect serum, urine and faecal samples) will occur at the Alfred Hospital, Monash University building, 55 Commercial Rd, Melbourne VIC
To safely induce intestinal stress in healthy subjects, participants will be administered a corticotrophin releasing hormone injection by a medical professional prior to commencing EEN and again after 3 weeks on EEN. Urine and blood samples will be taken following this injection.
Participants in this study will not be specifically be a follow up of the same participants enrolled in study ACTRN12621000568819, however if participants from the first study wish to participate in this study they are permitted to.
Intervention code [1] 327443 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336637 0
Intestinal permeability
Timepoint [1] 336637 0
Prior to commencement of EEN and on completion of 3 weeks of EEN
Secondary outcome [1] 429126 0
Intestinal epithelial integrity via biomarkers of bacterial translocation
Timepoint [1] 429126 0
Prior to commencement of EEN and on completion of 3 weeks of EEN
Secondary outcome [2] 429127 0
Regional intestinal transit times
Timepoint [2] 429127 0
Prior to commencement of EEN and on completion of 3 weeks of EEN
Secondary outcome [3] 429129 0
Faecal microbiota and mycobiota
Timepoint [3] 429129 0
Prior to commencement of EEN and on completion of 3 weeks of EEN
Secondary outcome [4] 429130 0
Psychological status of the subjects
Timepoint [4] 429130 0
Prior to commencement of EEN and on completion of 3 weeks of EEN
Secondary outcome [5] 430118 0
Intestinal epithelial integrity via biomarkers of epithelial injury
Timepoint [5] 430118 0
Prior to commencement of EEN and on completion of 3 weeks of EEN
Secondary outcome [6] 430119 0
Intestinal integrity via intestinal inflammation
Timepoint [6] 430119 0
Prior to commencement of EEN and on completion of 3 weeks of EEN
Secondary outcome [7] 430120 0
Intestinal intergrity via intestinal inflammation
Timepoint [7] 430120 0
Prior to commencement of EEN and on completion of 3 weeks of EEN
Secondary outcome [8] 430121 0
Colonic protein and carbohydrate fermentation
Timepoint [8] 430121 0
Prior to commencement of EEN and on completion of 3 weeks of EEN
Secondary outcome [9] 430122 0
Colonic protein and carbohydrate fermentation
Timepoint [9] 430122 0
Prior to commencement of EEN and on completion of 3 weeks of EEN
Secondary outcome [10] 430123 0
Regional gas profiles through the gastrointestinal tract (hydrogen, CO2)
Timepoint [10] 430123 0
Prior to commencement of EEN and on completion of 3 weeks of EEN
Secondary outcome [11] 430124 0
Colonic carbohydrate and protein fermentation
Timepoint [11] 430124 0
Prior to commencement of EEN and on completion of 3 weeks of EEN
Secondary outcome [12] 430125 0
Quality of life of the subjects
Timepoint [12] 430125 0
Prior to commencement of EEN and on completion of 3 weeks of EEN

Eligibility
Key inclusion criteria
18-60 years of age in good health
English speaking to provide informed consent
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Use of antibiotics, probiotics or supplementary prebiotics in previous 2 weeks
• Family history of IBD
• History of gastrointestinal conditions
• History of eating disorder
• Recent weight changes (>5% within past 1 month)
• Body Mass Index (BMI) <18.5 or >30
• Restrictive diets with potential major alteration to nutrient balance (e.g., vegan, paleo)
• Current psychological illness
• Smoker
• Taking medication known to alter intestinal barrier function
• Pregnant or breast feeding

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Sample size
As this is a pilot study with no data upon which to power, an initial cohort of 10 subjects will be studied.

Data analysis plan
Data analysis will be undertaken using the Statistical Package for Social Sciences (SPSS), version 20, (SPSS, Chicago, Inc):
• Descriptive statistics
• Statistical significance will be taken as p < 0.05.

Both per-protocol and intention-to-treat data will applied to all endpoints. Descriptive statistics will describe the outcome variables and baseline data will compared with that after intervention using, for example, Wilcoxon rank sum test for continuous variables and Chi squared test for categorical variables.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2024
Actual
Date of last participant enrolment
Anticipated
30/06/2024
Actual
Date of last data collection
Anticipated
30/06/2024
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 41712 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 315269 0
University
Name [1] 315269 0
Monash University
Country [1] 315269 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Rd, Clayton VIC 3800
Country
Australia
Secondary sponsor category [1] 317303 0
None
Name [1] 317303 0
Address [1] 317303 0
Country [1] 317303 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314189 0
Alfred Health Ethics Commitee
Ethics committee address [1] 314189 0
55 Commercial Rd, Prahran VIC 3004
Ethics committee country [1] 314189 0
Australia
Date submitted for ethics approval [1] 314189 0
28/06/2023
Approval date [1] 314189 0
19/10/2023
Ethics approval number [1] 314189 0

Summary
Brief summary
Exclusive Enteral Nutrition (EEN) reduces inflammation and allows complete gut healing in up to 80% of people with Crohn’s Disease (CD). EEN involves removing all food and replacing it with a liquid containing all essential nutrients for 6-8 weeks. This treatment is superior to steroids in treating inflammation and is being increasingly used across Australasia as first-line therapy, particularly in children. Despite EEN having been shown to be effective in numerous studies, the ways in which it works to reduce inflammation is still unknown and this study seeks to address the hypotheses by assessing how EEN works. The best way to assess how a therapy works to treat disease is to examine its impact in a 'normal' gut with limited confounders.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130726 0
Dr Emma Halmos
Address 130726 0
Alfred Centre, Central Clinical School, Level 5 99 Commercial Rd, Melbourne VIC 3004
Country 130726 0
Australia
Phone 130726 0
+61407324779
Fax 130726 0
Email 130726 0
emma.halmos@monash.edu
Contact person for public queries
Name 130727 0
Ms Sarah Melton
Address 130727 0
Alfred Centre, Central Clinical School, Level 5 99 Commercial Rd, Melbourne VIC 3004
Country 130727 0
Australia
Phone 130727 0
+61399030270
Fax 130727 0
Email 130727 0
sarah.melton@monash.edu
Contact person for scientific queries
Name 130728 0
Ms Sarah Melton
Address 130728 0
Alfred Centre, Central Clinical School, Level 5 99 Commercial Rd, Melbourne VIC 3004
Country 130728 0
Australia
Phone 130728 0
+61399030270
Fax 130728 0
Email 130728 0
sarah.melton@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data not to be shared publicly due to confidentially


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.