None listed
Conditions
Brief summary
Exclusive enteral nutrition (EEN) is a nutrition-based treatment for Crohn’s Disease (CD) with numerous advantages compared to current conventional therapies. While its efficacy has been demonstrated in adult CD patients, EEN remains an underutilised therapy due to a number of factors including uncertainties around the optimal regimen, monitoring and treatment targets. While frameworks have been established to aid decision-making and prescription, evidence to support these recommendations is limited. This multi-centre single arm pilot clinical study aims to meet this clinical need through prospectively evaluating the efficacy and feasibility of a protocolised approach to delivering exclusive enteral nutrition in adult patients with active Crohn's Disease. Participants who meet inclusion criteria and provide consent will receive a 6 week course of exclusive enteral nutrition under the guidance of an experienced dietitian with regular follow up. This study's primary outcome is the clinical response or remission and/or objective response or remission as demonstrated by normalisation of inflammatory biomarkers or resolution of intestinal inflammation on gastrointestinal ultrasound. Our study will also assess the impact of EEN on disease activity utilising clinical, biochemical, radiological, patient reported outcome measures. Adherence to the therapy and protocol as well as tolerability to EEN will also be assessed. Protocol feasbility and fidelity will be analysed along with health economic data to evaluate the cost-effectiveness of the protocol. Changes in colonic microbial composition, diversity and function post EEN therapy.
Interventions
Exclusive Enteral Nutrition (EEN) is a diet-based therapy for Crohn's disease that involves consumption of a specialised formula (polymeric, low-lactose, fibre-free liquid formula) while excluding all foods and fluids from diet with the exception of water. The liquid formula is contained in bottles and depending on estimated individual nutritional requirements, patients will typically consume 4-8 bottles over the course of a day to provide 100% of their required nutrition and caloric intake for
Exclusive Enteral Nutrition (EEN) is a diet-based therapy for Crohn's disease that involves consumption of a specialised formula (polymeric, low-lactose, fibre-free liquid formula) while excluding all foods and fluids from diet with the exception of water. The liquid formula is contained in bottles and depending on estimated individual nutritional requirements, patients will typically consume 4-8 bottles over the course of a day to provide 100% of their required nutrition and caloric intake for the day. All enrolled patients will have a baseline face-to-face dietetic assessment by a clinical dietitian (Dietitians Australia registered) prior to commencement of therapy. Estimated nutritional requirements and hence the amount of formula for daily consumption to meet these requirements will be calculated by the dietitian. Verbal education and generic written information about EEN (adapted from the patient information sheets by Australasian Society of Parenteral and Enteral Nutrition available online) will be given to patients. EEN will be supplied for the duration of therapy to the participants at no cost. Patients will have baseline blood and stool samples collected as well as radiological assessment with gastrointestinal ultrasound (GIUS) performed by a GIUS accredited gastroenterologist. Patients will be reviewed by a dietitian at week 2, week 4 and week 6 of therapy. Each appointment lasting 20-30 minutes in duration. Visits will be conducted face to face at the hospital dietitian clinic or via telephone. Patients will be assessed for adherence and tolerability to therapy, satiety, clinical response, and nutritional status. Adherence to therapy will be assessed by the dietitian. This involves direct questioning about self-reported amount of formula used, consumption of other foods or drinks, palatability. Food and fluid re-introduction will occur over 3-5 days at the end of 6 weeks of therapy. Verbal education and an information sheet on diet post EEN will be given to patients.
Sponsors
Central Adelaide Local Health Network (CALHN)
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Individuals with a formal diagnosis of Crohn’s Disease which may include histology consistent with CD, clinical diagnosis of active CD or disease visible by endoscopy or radiology or an elevated FC. 2. Active Crohn’s Disease as assessed by the treating clinician as demonstrated by: A. Clinical evidence with CDAI score > 150 AND/OR B. Radiological evidence with GIUS or magnetic resonance enterography (MRE) demonstrating active disease AND/OR C. Biochemical evidence with FCP > 100 microg/g 3. Individuals under the care of an IBD Service and Gastroenterologist across the Central Adelaide Local Health Network (CALHN) 4. Provide informed consent to participate in the study
Exclusion criteria
1. Individuals with significant medical or cognitive/psychiatric comorbidities that would impair ability to provide consent, consistently adhere to treatment or complete questionnaires required for study outcome measures 2. Individuals where EEN was prescribed for indications of pre-surgical optimisation or downgrading of disease prior; management of abdominal abscess 3. Individuals whose cause of symptoms is deemed to be infectious, iatrogenic or unrelated to underlying pathology of Crohn’s disease 4. Individuals with severe co-morbidities as judged by the treating clinician
Outcome results
None listed