None listed
Conditions
Brief summary
We will evaluate, in a proof-of-concept trial, whether exclusion of FEW-containing foods which are commonly reported as triggers in CD is efficacious in maintaining remission in patients. The study design will be a randomised controlled trial of the FEW foods exclusion diet compared to standard IBD dietary management. The primary outcome for this study is the composite intestinal ultrasound and faecal calprotectin. We predict that the diet low in fats, emulsifiers and wheat will maintain IBD remission for longer than the enhanced standard care diet
Interventions
Participants identified from the digestive health biobank who meet the inclusion criteria will be invited to enter the dietary trial. We will evaluate, in a proof-of-concept trial, whether exclusion of foods containing excess animal fats, emulsifiers and wheat (FEW), which are commonly reported as triggers in Crohn's disease is efficacious in maintaining remission in patients. The study design will be a randomised controlled trial of the FEW foods exclusion diet compared to standard inflammatory
Participants identified from the digestive health biobank who meet the inclusion criteria will be invited to enter the dietary trial. We will evaluate, in a proof-of-concept trial, whether exclusion of foods containing excess animal fats, emulsifiers and wheat (FEW), which are commonly reported as triggers in Crohn's disease is efficacious in maintaining remission in patients. The study design will be a randomised controlled trial of the FEW foods exclusion diet compared to standard inflammatory bowel disease dietary management. Participants randomised to FEW diet or enhanced standard care diet, with initial 1 hour dietitian consult and monthly 30 minute review (face-to-face or telehealth). A daily food checklist and once weekly automated 24 hour recall will be used to monitor adherence to the intervention.
Sponsors
Centre of Research Excellence in Digestive Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults aged 18 years or older 2. Males and females 3. Crohn’s disease; mild to moderate ileal or ileo-colonic disease (Crohn’s Disease Activity Index (CDAI) 150 – 450)
Exclusion criteria
1. Pregnancy 2. Post-resection surgery 3. Smokers 4. BMI greater than or equal to 30 5. Other autoimmune or atopic conditions 6. Other dietary restrictions or modifications that would prevent individual from completing dietary intervention (e.g., coeliac disease) 7. Unable to complete the study participation requirements
Outcome results
None listed