Crohn's disease
Conditions
Interventions
Crohn
diet
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 5.1 Population (base) Patients with active luminal Crohn*s disease 5.2 Inclusion criteria Patients >18 years, active luminal Crohn*s disease localized in colon and/ or terminal ileum, fecal calprotectin (fCAL) > 150 mg/g andSES-CD>5 or calpro >300 mg/g.
Exclusion criteria
Exclusion criteria: Patients unable or unwilling to provide informed consent, stenosis associated with symptoms, contra-indications to starting biological or immunomodulatory agent. Additionally, the relative Mediterranean diet score will be calculated based on self-reported dietary intake by a food frequency questionnaire to exclude patients already using a Mediterranean-like diet.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study period will last for 6 months, and the primary outcome measure will be adherence to the diet and diet related quality of life. | — |
Secondary
| Measure | Time frame |
|---|---|
| * Symptoms (CDAI) (standard medical care) * Fecal calprotectin at baseline, 3 and 6 months (standard medical care) * C-reactive protein at baseline, 3 and 6 months (standard medical care) * Health related quality of life, as measured using sIBDQ * Nutritional status and anthropometry (body weight, hand grip strength) * Diet quality (MDS-score) and food intake (3-day food diary) * Fibroscan analysis to assess effect of the diet on liver fat content * Waist hip ratio (as a marker for visceral adiposity) * Fitmate analysis to make a personalized metabolic expenditure estimation * BIVA analysis (baseline en 6 maanden) * AGE reader (baseline en 6 maanden) | — |
Countries
The Netherlands
Outcome results
None listed