Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000357459
Ethics application status
Approved
Date submitted
12/12/2024
Date registered
24/04/2025
Date last updated
24/04/2025
Date data sharing statement initially provided
24/04/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prospective assessment of the effects of Exclusive Enteral Nutrition on inflammation, epithelial integrity and body composition in patients with Crohn’s disease
Scientific title
Prospective assessment of the effects of Exclusive Enteral Nutrition on inflammation, epithelial integrity and body composition in patients with Crohn’s disease
Secondary ID [1] 313535 0
None
Universal Trial Number (UTN)
Trial acronym
PrEEN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's disease 336006 0
Condition category
Condition code
Oral and Gastrointestinal 332587 332587 0 0
Crohn's disease
Diet and Nutrition 332914 332914 0 0
Other diet and nutrition disorders
Inflammatory and Immune System 332915 332915 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exclusive Enteral Nutrition (EEN) is a dietary therapy used to treat active Crohn's disease. It involves the provision of a specialised liquid nutrition formula (nutritionally complete, fibre free) for 6-8 weeks under the supervision of Inflammatory Bowel Disease (IBD) dietitian and gastroenterologist to reduce intestinal inflammation.

Patients who are commencing EEN at our centre as a part of their treatment, will be offered enrolment in the study. The research dietitian calculates estimated nutrition requirements using equations (that account for weight, gender, age, disease activity and physical activity) and tailors the EEN regime to the estimated requirements (these can be reviewed at each review if there is a change to weight, activity). Participants will be assess at baseline (face-to-face) by the research dietitian and reviewed at week 1, 2, 4 via telehealth/phone with a face-to-face appointment at week 6. Assessment throughout the study comprise anthropometry (including body composition), clinical symptoms, tolerance, adherence, biochemistry and ultrasound. Participants complete a daily diary throughout the study to assess adherence, as well as weekly self reported adherence as per an adherence scale).

EEN intervention: 200ml bottles across the day to meet individuals estimated nutrition requirements (ie. 5-8 bottles daily, depending on individual patient characteristics). This is provided to patients via the standard of care processes for accessing EEN at this institution (ordered by the dietitian and sent to patients home).
Intervention code [1] 330123 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340096 0
Sonographic response
Timepoint [1] 340096 0
6 weeks post commencement of EEN
Secondary outcome [1] 442638 0
Inflammation
Timepoint [1] 442638 0
Baseline, week 2 & week 6 post EEN commencement
Secondary outcome [2] 442639 0
Intestinal permeability (small bowel)
Timepoint [2] 442639 0
Week 6 post EEN commencement
Secondary outcome [3] 442640 0
Clinical disease activity (remission)
Timepoint [3] 442640 0
Week 6 post EEN commencement
Secondary outcome [4] 442641 0
Intestinal inflammation
Timepoint [4] 442641 0
Baseline, week 2 & week 6 post EEN commencement
Secondary outcome [5] 442642 0
Skeletal muscle mass
Timepoint [5] 442642 0
Baseline, week 6 post EEN commencement
Secondary outcome [6] 442643 0
Epithelial injury
Timepoint [6] 442643 0
Week 6 post EEN commencement
Secondary outcome [7] 442644 0
Bacterial translocation
Timepoint [7] 442644 0
week 6 post EEN commencement
Secondary outcome [8] 442645 0
Faecal microbiota
Timepoint [8] 442645 0
Baseline, week 6 post EEN commencement
Secondary outcome [9] 442646 0
Adverse effects (ie. poor tolerance to EEN formula including significant nausea, bowel obstruction, worsened diarrhoea)
Timepoint [9] 442646 0
Baseline and week 1, 2, 4 & 6 after EEN commencement
Secondary outcome [10] 442647 0
Adherence
Timepoint [10] 442647 0
Week 1,2,4 & 6 post EEN commencement
Secondary outcome [11] 444091 0
Quality of life
Timepoint [11] 444091 0
Baseline and 6 weeks post EEN commencement
Secondary outcome [12] 444096 0
Metabolomic changes
Timepoint [12] 444096 0
Baseline, 6 weeks after EEN commencement
Secondary outcome [13] 444098 0
Muscle quanitity
Timepoint [13] 444098 0
Baseline and week 6 after EEN commencement
Secondary outcome [14] 444099 0
Muscle function
Timepoint [14] 444099 0
Baseline and 6 weeks after EEN commencement
Secondary outcome [15] 444101 0
Visceral adipose tissue
Timepoint [15] 444101 0
Baseline and 6 weeks after EEN commencement
Secondary outcome [16] 444103 0
Fat mass
Timepoint [16] 444103 0
Baseline and 6 weeks after EEN commencement
Secondary outcome [17] 446690 0
Muscle quantity
Timepoint [17] 446690 0
Baseline and week 6 after EEN commencement
Secondary outcome [18] 446691 0
Fat mass index
Timepoint [18] 446691 0
Baseline and week 6 after EEN commencement
Secondary outcome [19] 446692 0
Fat mass percentage
Timepoint [19] 446692 0
Baseline and week 6 after EEN commencement

Eligibility
Key inclusion criteria
Patients with confirmed diagnosis of Crohn's disease with active inflammation necessitating the use of EEN at Alfred Health (IBD clinic or IUS clinic) and stable medical therapy for previous 2 months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Significant medical or cognitive/psychiatric comorbidities that would impair ability to provide consent
2. Ineligibility for Medicare
3. Inability to speak or read English to give 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)
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 design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
11/10/2024
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
50
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27383 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 43481 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 317991 0
University
Name [1] 317991 0
Monash University
Country [1] 317991 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 320336 0
Hospital
Name [1] 320336 0
Alfred Health
Address [1] 320336 0
Country [1] 320336 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316660 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 316660 0
Ethics committee country [1] 316660 0
Australia
Date submitted for ethics approval [1] 316660 0
25/07/2024
Approval date [1] 316660 0
07/10/2024
Ethics approval number [1] 316660 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138570 0
Dr Emma Halmos
Address 138570 0
Alfred Centre, Central Clinical School, Level 5 99 Commercial Rd, Melbourne VIC 3004
Country 138570 0
Australia
Phone 138570 0
+61407324779
Fax 138570 0
Email 138570 0
[email protected]
Contact person for public queries
Name 138571 0
Sarah Melton
Address 138571 0
Alfred Centre, Central Clinical School, Level 5 99 Commercial Rd, Melbourne VIC 3004
Country 138571 0
Australia
Phone 138571 0
+613 9903 0270
Fax 138571 0
Email 138571 0
[email protected]
Contact person for scientific queries
Name 138572 0
Sarah Melton
Address 138572 0
Alfred Centre, Central Clinical School, Level 5 99 Commercial Rd, Melbourne VIC 3004
Country 138572 0
Australia
Phone 138572 0
+613 9903 0270
Fax 138572 0
Email 138572 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.