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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Crohn's disease
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Crohn’s disease (CD) results in chronic intestinal inflammation, is of increasing incidence both in the developed and developing world and has a marked impact on patient quality of life. The prevalence of CD is 10.6 per 100,000 people in the UK and represents a significant annual financial burden of around €16.7 million in Europe.
A wide range of nutrients and food components have been investigated for their role in the pathogenesis and course of CD. A common theme suggests that CD risk is associated with a “Western diet”, including high fat, high sugar and processed foods. However, intervention studies that exclude specific aspects of the diet such as sugar or that compare low and high fat diets have failed to show effectiveness in practice. Observational human and experimental animal studies suggest that certain food additives used extensively by the food industry play a role in the pathogenesis and natural history of CD. However, to date no evidence exists for the effectiveness of a diet low in these food additives in CD.
Therefore, the aim of this study is to investigate the effects of a diet low in certain food additives compared to a normal UK diet on CD activity, health-related quality of life, gut bacteria, gut permeability, gut inflammation and dietary intake, in patients with mildly active, stable CD. We will recruit patients with mildly active CD and will randomise them to receive either the diet low in the food additives of interest, or the diet representative of a normal UK diet. Patients will follow the diet for 8 weeks and will attend study visits at the start and end of the trial, at which points questionnaires will be completed and samples will be collected.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. Changes in dose to azathioprine, 6-mercaptopurine, methotrexate or anti-TNF-α agents or other biologics during the preceding 8 weeks, oral 5-ASA during the preceding four weeks. Currently receiving oral prednisolone/budesonide or discontinued within the last 4 weeks, unless they are on a stable dose of 10 mg/day or less prednisolone (3 mg or less budesonide) for at least 4 weeks with the intention to continue this long term.2. Used rectal 5-ASA or rectal steroids in the preceding 4 weeks 3. Previous extensive bowel resection, defined as having had > 2 intestinal resections, a sub-total colectomy or documented short bowel syndrome4. Poorly controlled bile acid malabsorption5. Current stoma6. Recent use of the following treatments: antibiotics, probiotics, prebiotic or fibre supplements in the preceding four weeks, NSAIDs during the preceding week7. Full bowel preparation for a diagnostic procedure in preceding 4 weeks8. Comorbidities including sepsis/fever, diabetes or coeliac disease, or other concomitant serious comorbidity e.g. significant psychiatric, hepatic, renal, endocrine, respiratory, neurological or cardiovascular disease9. Exclusive enteral nutrition in the past 8 weeks10. Assessed as at nutritional risk, as defined by any of the following:10.1 BMI < = 18.5 kg/m210.2 Previous or current eating disorder10.3 Currently receiving prescribed oral nutritional supplements11. Following a restrictive diet (e.g. multiple restrictions due to numerous self-reported allergies) as judged by the dietitian12. Reported pregnancy or lactation
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Aaron
Bancil
+44 (0)207 848 4552
aaron.bancil@kcl.ac.uk
The study is sponsored by King's College London and funded by Leona M. and Harry B. Helmsley Charitable Trust; National Institute for Health Research.
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Or CPMS 41991
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
