None listed
Conditions
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.
Interventions
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
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.
Sponsors
Monash University
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 60 Years
Healthy volunteers
Yes
Inclusion criteria
18-60 years of age in good health English speaking to provide informed consent
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
Outcome results
None listed