None listed
Conditions
Brief summary
The purpose of this study is to investigate the feasibility and effectiveness of the CDED in adult patients with Crohn’s disease on outcomes including compliance of the diet, changes in nutrition impact symptoms and quality of life; in comparison to their baseline diet. It is hypothesized that if patients are compliant with the CDED and the CDED is completed appropriately and in its entirety, it will be a feasible treatment strategy and effective in inducing remission for adult patients with Crohn’s Disease.
Interventions
Crohns Disease Exclusion Diet (CDED). In summary the diet involves the consumption of whole foods but reduces exposure to dietary components that have been shown to induce a flare. The whole foods are also combined with partial enteral nutrition (PEN), or drinks that will supplement the macro & micro nutrients missing from the diet. The main food groups excluded are, gluten, wheat, dairy products, some animal fat, processed meats, emulsifiers, canned foods, soft drinks, alcohol & and coffee. With the inclusion of resistant starch and pectin fibres. The CDED involves 3 phases over 12+ weeks. A dietitian will conduct all education sessions with the participants. They will receive education on all 3 phases of the diet and information pertaining to the PEN. The education will be given to the patient before the commencement of phase 1 - they will be educated on all 3 phases in one sitting. The sessions will take approx. 1hr. Phase 1 (6 weeks) is 50% CDED mandatory & allowed foods+ 50% Partial Enteral Nutrition (PEN). Phase 2 (6 weeks) will be commenced and education provided. Phase 2 is 75% CDED mandatory & allowed foods+ 25% Partial Enteral Nutrition (PEN). The PEN will be provided to the participants free of charge. Nutricia Australia will provide 142 cartons of ‘Fortisip’ (200ml bottles) to the study in four different flavours (vanilla, chocolate, strawberry & banana). The participants will be allowed to taste test each flavour and are able to pick as many flavours as they choose to complete the study. The participants will each be assigned a specific number of ‘Fortisip’ (200ml bottles) that will individually suit their calculated nutrition requirements. The ‘Fortisip’ supplements (200ml bottles) are nutritionally complete, medical grade oral nutrition supplements that can be consumed as a sole source of nutrition if required. As per the Nestle Modulife CDED Program & DECCAN Clinical Practice Toolkit8, Phase 3 (Maintenance Phase) has limited evidence related to maintaining a restrictive diet in the long term. The participants will be advised to gradually re-introduce their usual diet. They will be educated on maintaining a healthy, well-balanced diet in line with the Australian Guide to Healthy Eating. The participants will be advised to continue avoiding processed foods including processed meats, soft drink, ultra-processed foods and excessive caffeine and alcohol. At the end of each review a supplement stocktake will be completed to compare the number of ‘Fortisip’ supplements (200ml bottles) consumed to the volume of supplements the participant should be drinking (i.e. as calculated) to manage reports of over/under reporting. After weeks 1,2,6,8 &12 of the diet a review will be conducted to assess 24hr recall (i.e. dietary intake), gastrointestinal symptoms using the Gastrointestinal Symptom Scale, and compliance to the diet using the Medication Adherence Rating Scale.
Sponsors
Study design
Eligibility
Inclusion criteria
• Male or female participant’s 18 years or older with moderate to severe luminal Crohn’s Disease • Crohns Disease Activity Index (CDAI) greater than or equal to 220 • C Reactive Protein (CRP) greater than or equal to 15 OR Platelets greater than or equal to 450 OR Faecal Calprotectin (FCP) greater than 150 • Patients not excluded if they had received Mesalamine or a stable dose of immunomodulator for greater than 6 weeks
Exclusion criteria
• Patients without Crohn’s disease, patients with ulcerative colitis and patients with Inflammatory Bowel Disease - Unknown (IBD-U) • Patients with Crohn’s disease in clinical remission (CDAI score <220) • Patients < 18 years old • Patients receiving steroids or who have started an immunomodulator in the previous 6 weeks, current or past biological treatment • Patients with complicated, extraintestinal or active penetrating perianal disease (abscess or fistula) • Fixed non-inflammatory stricture or small bowel obstruction • Normal CRP (<15g) & normal FCP (<150) • Sclerosing cholangitis • Pregnancy • Patients who have been treated by PEN that exceeds 50% of nutritional needs 2 weeks before enrolment • Positive Clostridium difficile toxin • Patients who are unable to consent due to language barriers or cognitive function • Patients who are culturally and linguistically diverse (CALD) or non-english speaking background (NESB) • Patients who have documented cognitive impairment