Crohn's disease (CD), a type of inflammatory bowel disease (IBD), is on the rise globally. Although medical treatments have advanced, CD still leads to significant health issues due to disease progression and medication side effects. Exclusive enteral nutrition (EEN) is a recommended first-line treatment for pediatric CD, proving more effective than oral corticosteroids without side effects. However, EEN demands strict adherence, making it challenging for patients, particularly adults.
In 2019, Levine et al. found that a combination of a specific diet (CD exclusion diet, CDED) and partial enteral nutrition (PEN) was as effective as EEN in inducing remission in pediatric patients, with better tolerance and adherence. CDED focuses on whole foods and aims to minimize harmful dietary components affecting the gut.
In clinical practice, an adapted CDED (aCDED) has been used to provide more food choices, but it lacks validation in clinical trials. An aCDED that considers regional and seasonal food variations could enhance patient adherence and align with modern dietary preferences.
This study aims to compare the quality of life during a flare up of Crohn's disease treated with standard of care or an adapted Crohn's disease exclusion diet with partial enteral nutrition in adult patients.
Must be ≥ 18 years at the time of signing the informed consent.
Macroscopic small bowel involvement, or isolated large bowel disease confined to the right or transverse colon confirmed by endoscopy
Patients with a Crohn's disease activity index (CDAI) of ≥ 150
Patients will not be excluded if they have received 5ASA or an immunomodulator for > 8 weeks and the dose is stable, or if they start a thiopurine concurrently, as thiopurines are not considered sufficient to induce remission in active disease before 8 weeks as an isolated therapy
Patients with with minimal disease activity (CDAI <150) or severe disease (CDAI >450)
Patients who have received corticosteroids of any kind in the previous 4 weeks
Patients who have started an immunomodulator in the previous 8 weeks
Any current biological or small molecule treatment
Parallel
aCDED + Modulen
Dietary supplementUnique diet + partial enteral nutrition (PEN): This group will receive as follows: * Weeks 1-6: 50% of dietary needs from PEN (Modulen, ModuLife phase I) and 50% from a limited whole food diet * Weeks 7-12: 25% of dietary needs from PEN (Modulen, ModuLife phase II) and 75% from a limited whole food diet * Weeks 12-48: liberal diet and Modulen as needed
Prednisolone
Drug1 mg/kg, tapering scheme
Improvement of Quality of Life
Measuring Quality of Life (QoL) using the IBD-Q-32-questionnaire (Inflammatory Bowel Disease Questionnaire with 32 items) * measuring the relative improvement compared to baseline * Minimum score: 32 points = bad QoL * Maximum score: 224 points = excellent QoL
Remission (defined as CDAI≤150)
Using the CDAI (Crohn's Disease Activity Index) to measure activity in the past 7 days * score \< 150 points = remission * score 150-219 points = mild disease activity * score 220-450 points = moderate to severe disease activity * score \> 450 points = severe disease activity
Reduced fecal calprotectin
Patients' adherence to the diet assessed by cessation of therapy because of patients' refusal to continue and by a questionnaire
Improvement of markers of malnutrition compared between the treatment arms
Click on the lead sponsor to view all of their trials.
University Hospital Tuebingen
Lead sponsor
Société des Produits Nestlé (SPN)
Collaborator
