Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000301460
Ethics application status
Approved
Date submitted
28/01/2025
Date registered
15/04/2025
Date last updated
15/04/2025
Date data sharing statement initially provided
15/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Does the duration of Exclusive Enteral Nutrition affect frequency of bowel motions in adults with Acute Severe Ulcerative Colitis (ASUC)?
Scientific title
Is the duration (1 week versus 3 weeks) of Exclusive Enteral Nutrition (EEN) associated with decreased frequency of bowel motions, in adult patients admitted to hospital with Acute Severe Ulcerative Colitis (ASUC)?
Secondary ID [1] 313976 0
NONE
Universal Trial Number (UTN)
Trial acronym
EEN in ASUC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Severe Ulcerative Colitis 336469 0
Condition category
Condition code
Oral and Gastrointestinal 332987 332987 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a combined retrospective and prospective cohort clinical intervention study comparing three groups. Group 1: a retrospective control cohort of patients admitted between 1st June 2020 and 1st June 2022 who received standard medical therapy only, including treatment escalation as determined by the treating gastroenterologist. Group 2: a retrospective cohort of patients admitted between 1st June 2022 and 1st December 2024 who received exclusive enteral nutrition (EEN) for one week. Group 3: a prospective cohort of patients who will be admitted to Logan Hospital (LGH) with acute severe ulcerative colitis (ASUC) and receive EEN for three weeks.

The volume of EEN required for each patient is calculated using weight-based formulas, which determine the individual’s energy and protein requirements as outlined in the Queensland Health Estimating Nutritional Requirements guidelines. Ref: https://www.health.qld.gov.au/__data/assets/pdf_file/0022/144175/est-req.pdf
Patients consume only the prescribed EEN formula and water, with no other food or drink recommended. EEN is provided in tetra packs, and most patients will require between 6–8 drinks per day to meet 100% of their macronutrient requirements (calories, carbohydrates, protein, and fats). These will be consumed instead of meals.

EEN is commenced on Day 0 and continued for either one or three weeks, incorporating the duration of the hospital stay, which is typically five days unless treatment escalation is required. Each patient will receive a script for any additional days of EEN needed, which is provided by the Dietitian Assistants before discharge. Consent for EEN is obtained by a doctor or dietitian on admission. A full nutritional assessment is conducted by the dietitian as close to admission as possible, with regular monitoring throughout the hospital stay. The dietitian will work closely with the multidisciplinary team to assess the patient’s progress on EEN.

To assess adherence to the intervention, eligible patients will provide consent, and dietitians will closely monitor compliance—initially daily while in hospital, or until the patient is meeting their nutritional requirements. Follow-up will be guided by individual patient needs and dietitian clinical reasoning.

Once ethics approval is granted, data for the retrospective control and one-week EEN cohorts will be obtained from electronic medical records (IEMR). The one-week EEN group will be a retrospective cohort obtained from an approved ethics-exempt clinical audit (EX/2023/QMS/97862), including patients admitted between 1st June 2022 and 1st December 2024.
Intervention code [1] 330415 0
Treatment: Other
Comparator / control treatment
The control group will include a retrospective cohort admitted between 1st June 2020 and 1st June 2022 who underwent standard medical therapy only, including escalation of treatment as needed, and determined by the treating gastroenterologist.
Control group
Historical

Outcomes
Primary outcome [1] 340525 0
Number of (bloody) bowel motions / day
Timepoint [1] 340525 0
Baseline, Day 7 or as close as possible (for all groups) Day 21 or as close as possible (for 3-week group only)
Secondary outcome [1] 444345 0
Disease activity - assessed as a composite outcome
Timepoint [1] 444345 0
During the initial admission and within the first 6-12 months post discharge from hospital.
Secondary outcome [2] 444346 0
Disease severity - assessed as a composite outcome:
Timepoint [2] 444346 0
Within the initial 3 days following scope
Secondary outcome [3] 444347 0
Escalation of therapy i.e., progression to biologics therapy or surgery (colectomy).
Timepoint [3] 444347 0
Day 3 or during this admission
Secondary outcome [4] 444348 0
QoL - determined by an absence of disability and normalized health-related quality of life are long-term treatment targets
Timepoint [4] 444348 0
before and after 3 week intervention group

Eligibility
Key inclusion criteria
Inclusion criteria for both the 1-week retrospective EEN group and the 3-week prospective EEN groups are the same and include:
• Adults (18 years of age or older)
• Patients admitted to Logan Hospital with Acute Severe Ulcerative Colitis (ASUC) defined by MAYO Score >10 (ASUC) and Truelove and Witt Criteria determined by the treating gastroenterologist and subsequently referred to the dietitian.
• Patient able to and willing to consent to undertake 3-weeks on EEN in conjunction with standard medical therapy.
• Patients able and willing to provide written, informed consent to participate in this research project.
Inclusion criteria for the control group included adult patients admitted with ASUC between 1st June 2020 and 1st June 2022 who underwent standard medical therapy only, including escalation of treatment as needed, and determined by the treating gastroenterologist.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for both the 1-week retrospective EEN group and the 3-week prospective EEN groups are the same and include:
• Patients under the age of 18 years.
• Complications on admission (e.g., toxic megacolon, bowel perforation, or ileus)
• Unable or unwilling to tolerate EEN as determined by Visual Analogue Scale (VAS)
• Patients with an existing dairy allergy
• Unable or unwilling to undertake EEN or provide written informed consent to participate in the research project.
• Patients who have previously been admitted to LGH for ASUC medical treatment within the last 6 years.
• Patients who are cognitively impaired
• Patients who do not understand spoken or written English and an interpreter is unavailable.
Given the control group were adult patients admitted to Logan hospital who underwent standard medical intervention, there was no exclusion criteria other than only patients over the age of 18yrs were included.

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
Other design features
Control group and 1 week EEN group are both retrospective
3 week group is the only prospective - therefore all new eligible patients will be assigned to the 3 week group
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be entered into Excel and analysed in SPSS. Descriptive statistical tests will be used to describe the patients in each of the three arms. Chi-squared and ANOVAs (or non-parametric equivalent) will be used to assess differences in outcomes between the groups. McNemars chi-squared and paired t-tests may also be used to assess changes within groups on admission and discharge.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/06/2025
Actual
Date of last participant enrolment
Anticipated
30/05/2027
Actual
Date of last data collection
Anticipated
1/12/2027
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 27556 0
Logan Hospital - Meadowbrook
Recruitment postcode(s) [1] 43670 0
4131 - Meadowbrook

Funding & Sponsors
Funding source category [1] 318298 0
Hospital
Name [1] 318298 0
In-kind funding - Logan Hospital, Metro South Health, Brisbane, QLD
Country [1] 318298 0
Australia
Primary sponsor type
Individual
Name
Liz Purcell, Gastroenterology Dietitian & Team Leader, Nutrition and Dietetics Dept, Logan Hospital, Metro South Health, QLD
Address
Country
Australia
Secondary sponsor category [1] 320682 0
None
Name [1] 320682 0
Address [1] 320682 0
Country [1] 320682 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316934 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 316934 0
Ethics committee country [1] 316934 0
Australia
Date submitted for ethics approval [1] 316934 0
05/02/2025
Approval date [1] 316934 0
24/03/2025
Ethics approval number [1] 316934 0
HREC/2025/QMS/115513

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

Contacts
Principal investigator
Name 139474 0
Ms Liz Purcell
Address 139474 0
Logan Hospital, Cnr Armstrong Rd &, Loganlea Rd, Meadowbrook, QLD 4131
Country 139474 0
Australia
Phone 139474 0
+61 730896382
Fax 139474 0
Email 139474 0
[email protected]
Contact person for public queries
Name 139475 0
Liz Purcell
Address 139475 0
Logan Hospital, Cnr Armstrong Rd &, Loganlea Rd, Meadowbrook, QLD 4131
Country 139475 0
Australia
Phone 139475 0
+61 730896382
Fax 139475 0
Email 139475 0
[email protected]
Contact person for scientific queries
Name 139476 0
Liz Purcell
Address 139476 0
Logan Hospital, Cnr Armstrong Rd &, Loganlea Rd, Meadowbrook, QLD 4131
Country 139476 0
Australia
Phone 139476 0
+61 730896382
Fax 139476 0
Email 139476 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.