Diet as add on therapy for active Crohn*s disease
- Conditions
- Crohn's disease10017969
- Registration Number
- NL-OMON45688
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 50
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
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.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The study period will last for 6 months, and the primary outcome measure will<br /><br>be adherence to the diet and diet related quality of life.</p><br>
- Secondary Outcome Measures
Name Time Method <p>* Symptoms (CDAI) (standard medical care)<br /><br>* Fecal calprotectin at baseline, 3 and 6 months (standard medical care)<br /><br>* C-reactive protein at baseline, 3 and 6 months (standard medical care)<br /><br>* Health related quality of life, as measured using sIBDQ<br /><br>* Nutritional status and anthropometry (body weight, hand grip strength)<br /><br>* Diet quality (MDS-score) and food intake (3-day food diary)<br /><br>* Fibroscan analysis to assess effect of the diet on liver fat content<br /><br>* Waist hip ratio (as a marker for visceral adiposity)<br /><br>* Fitmate analysis to make a personalized metabolic expenditure estimation<br /><br>* BIVA analysis (baseline en 6 maanden)<br /><br>* AGE reader (baseline en 6 maanden)<br /><br></p><br>