None listed
Conditions
Brief summary
Inflammatory bowel disease, including Ulcerative Colitis (UC), causes chronic inflammation of the GI tract. UC primarily affects the large bowel and rectum, with a prevalence of ~334 per 100,000 Australians. It leads to severe symptoms, comprising of bloody diarrhoea and abdominal pain. Acute Severe Ulcerative Colitis (ASUC) is a life-threatening extension of UC, often unresponsive to corticosteroids. Exclusive Enteral Nutrition (EEN), a safe nutritionally complete liquid diet, shows promise as an alternative treatment. While EEN is well-researched and its safety well recognised, it’s effectiveness in large bowel disease (UC) is less well understood. Given the limited evidence in ASUC, this cohort study aims to investigate the impact of 1 week versus 3 weeks of EEN on disease activity, frequency of bowel motions, and quality of life in adults admitted to Logan Hospital (LGH) with ASUC. We will compare outcomes between a retrospective control group who did not receive EEN with prospective cohorts who received either 1 week or 3 weeks of EEN. All groups also received standard medical therapy. If the results show no significant difference in clinical outcomes or remission rates between the two durations of EEN, it suggests that clinical improvements can be achieved with a shorter duration of EEN. This finding would make EEN treatment more acceptable and feasible for adults with ASUC, potentially improving patient adherence and reducing the treatment burden.
Interventions
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:
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.
Sponsors
Liz Purcell, Gastroenterology Dietitian & Team Leader, Nutrition and Dietetics Dept, Logan Hospital, Metro South Health, QLD
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed