None listed
Conditions
Brief summary
Crohn's disease (CD) is a chronic inflammatory condition of the bowel that carries a 70% lifetime risk of requiring surgical resection due to stricture formation or bowel perforation. CD often requires prolonged courses of immunosuppressive medications in order to induce remission, and these medications in themselves carry their own sets of risks. Exclusive Enteral Nutrition (EEN) has proven successful in inducing remission in pediatric CD patients. EEN is a polymeric supplement feed that is meant to provide all of the daily requirements of macro and micro nutrients. It is intended that patients consume this polymeric supplement feed for at least 80% of their daily nutritional requirement. Uncontrolled studies and small controlled trials suggest that there are benefits of EEN in adult CD patients as well but to date there has been no large controlled trial to formally test this hypothesis. The proposed study will seek to test in a randomized controlled trial the hypothesis that EEN can improve outcomes in patients with severe CD affecting the terminal ileum, which is a part of the bowel that is most commonly affected by CD. The study will have two phases. Phase 1, will see participants randomized into two groups, either EEN or standard of care calorie matched diet for 6 weeks prior to their planned operation. The primary outcome compared between the two groups at the end of phase 1 is both clinical disease remission and reduction of bowel wall swelling of the terminal ileum as measured by Magnetic Resonance (MR) enterography, an imaging modality commonly used in CD. Other secondary outcomes which will be assessed at the end of Phase 1 include quality of life, nutritional status, microbiome comparison, mean intestinal permeability, tolerability of diet, health economics and predicative markers for response. Following their surgical resection, participants will be re-randomized for phase 2 of the trial. Phase 2 of the trial will seek to test the hypothesis that partial enteral nutrition for 6 months as compared to standard of care calorie matched diet results in improved outcomes following surgical resection of the terminal ileum. The primary outcome at the end of phase 2 will be assessment of recurrence via colonoscopy after 6 months of the prescribed diet. Other secondary outcomes which will be assessed at the end of Phase 2 include quality of life, nutritional status, microbiome comparison, tolerability of diet and health economics.
Interventions
Randomized Ileal Crohn’s disease study of exclusive Enteral Nutrition (RICE) is a randomised controlled study for the treatment of ileal Crohn’s disease (CD) randomising EEN versus standard therapy in a single-blinded trial design. In Phase 1 of the study consenting patients with either severe Crohn's disease or symptomatic terminal ileal strictures/ perforation requiring surgical resection are randomised to receive EEN using polymeric formula versus calorie-matched standard of care diet for 6 w
Randomized Ileal Crohn’s disease study of exclusive Enteral Nutrition (RICE) is a randomised controlled study for the treatment of ileal Crohn’s disease (CD) randomising EEN versus standard therapy in a single-blinded trial design. In Phase 1 of the study consenting patients with either severe Crohn's disease or symptomatic terminal ileal strictures/ perforation requiring surgical resection are randomised to receive EEN using polymeric formula versus calorie-matched standard of care diet for 6 weeks (in the subgroup of patients requiring surgery this will be taken in the 6 weeks immediately pre-surgery). In phase 2, patients that required surgery will undergo post-operative re-randomization to determine the effects of 6 months of partial enteral nutrition (PEN) on the prevention of post-operative CD. Other post-operative patients who will have resection of the terminal ileum may be recruited directly into phase 2 of the study without having participated in phase 1. In phase 1 of the study, participants will consume EEN in the form of Nestle Modulen, prescribed by a dietician to meet all their nutritional requirements. The aim is to achieve compliance for >80% of consumed calories in the form of Nestle Modulen, which will be monitored through use of food diaries and regular follow up. In Phase 2 of the study Nestle Modulen will be consumed for about 50-60% of normal daily calorie intake and again adherence will be monitored through the use of a food diary.
Sponsors
Concord Hospital, Department of Gastroenterology
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Participant must meet all of the inclusion criteria below at time of enrolment to be eligible to participate in phase 1 of the study 1. Crohn’s disease involving the terminal ileum, established diagnosis >6 months 2. Aged 18 – 70 inclusive 3. Ileal complicated Crohn’s disease requiring laparoscopic / open ileal (or small bowel segmental) resection, OR severe ileal Crohn’s disease Participant must meet all of the inclusion criteria below at time of surgery to be eligible to participate in phase 2 of the study: 1. Crohn’s disease involving the terminal ileum, established diagnosis >6 months 2. Aged 18 – 70 inclusive 3. Ileal complicated Crohn’s disease undergoing laparoscopic / open ileal (or small bowel segmental) resection 4. Terminal ileum can be reached by colonoscopy.
Exclusion criteria
Participant must not meet any of the exclusion criteria below at time of enrolment to be eligible to participate in either phase 1 or phase 2 of the study 1. Unable to consent, comply or complete the study and associated procedures (such as understanding of questionnaires) 2. Requirement for emergency small bowel resection eg. those with uncontrolled sepsis or peritonitis or complete bowel obstruction 3. Short bowel syndrome or any other significant gastrointestinal disease (eg irritable bowel syndrome, active neoplasm, diverticulitis etc) 4. Colectomy, stoma formation ie. non-primary anastomosis, or strictureplasty without small bowel resection 5. Resection for malignancy or known colorectal dysplasia (apart from polyps that have been completely removed) 6. Pregnancy, lactation or unwillingness to practice an effective method of contraception during the study period 7. Ulcerative colitis or IBD unclassified 8. Comorbidity or psychiatric disorder sufficiently severe to jeopardize participation
Outcome results
None listed