"Tasty&Healthy" Dietary Approach for Crohn's Disease

Summary

Participation Requirements

Description

The investigators plan to conduct a set of three studies: Two randomized controlled trials (RCT) both including the Tasty&Healthy dietary intervention for 8 weeks in CD patients aged 6-24 years vs. 1) EEN in mild-moderate CD, and the other RCT vs. 2) a control group continuing their habitual diet in...

The investigators plan to conduct a set of three studies: Two randomized controlled trials (RCT) both including the Tasty&Healthy dietary intervention for 8 weeks in CD patients aged 6-24 years vs. 1) EEN in mild-moderate CD, and the other RCT vs. 2) a control group continuing their habitual diet in those with mucosal inflammation despite stable medical treatment, but who are in clinical remission or have only minimal symptoms not requiring immediate treatment. As a third study, responders from both trials will be offered to participate in an open label extension personalized-diet study of further 16 weeks (total 24 weeks), in which gluten and dairy will be gradually re-introduced based on repeated monthly home assays of FC while otherwise following the Tasty&Healthy dietary intervention in a treat-to-target management approach. Patients will be evaluated at baseline, week 4 and week 8 with additional weekly phone visits to ensure adherence with the diets and address questions. The extension study will include two clinic visits at weeks 16 and 24 and a monthly call to ensure adherence. The investigators hope to establish a dietary-approach which is simpler to implement than current nutritional alternatives. It will enable high flexibility in the allowed foods and does not require liquid formula. In turn, this could position Tasty&Healthy, not merely for inducing remission, but also as a feasible maintenance strategy in selected patients.

Tracking Information