Extrait

Background and study aims People with Crohn's disease (a long-term condition causing inflammation of the lining of the digestive system) may experience a number of nutritional deficiencies even at times when their disease is not active. This study aims to look at the feasibility of carrying out a study to compare dietary counselling to standard written information to manage under-nutrition in people with Crohn's disease. Who can participate? Patients aged 18-65 years with Crohn's disease in its inactive state attending outpatient appointments at Guy's and St Thomas' NHS Trust. What the study involve? Participants will be randomly allocated to one of two groups. Both groups will receive standard care in the form of written dietary information increasing portion size, meal frequency, food choice, nutrient density and food fortification. One group will also receive dietary counselling tailored to provide an additional 600 kcal/d for a period of two months. At the end of the study, interviews will be conducted to measure participant acceptability. What are the possible benefits and risks of participating? The participants may view the opportunity to receive well-established dietary counselling as a benefit of the study. The main disadvantages are the burden of participating in a study, the need to make dietary changes and the need to visit the research centre to carry out measurements on two occasions. Where is the study run from? Guy's and St Thomas' NHS Trust, UK. When is the study starting and how long is it expected to run for? The recruitment period is expected to last from February to May 2014. Who is funding the study? King's College London, UK Who is the main contact? Sheena Visram [email protected]

Critère d'inclusion

• Nutritional support for inactive Crohn's disease

Liens

• ictrp
• isrctn