IBD, Crohn's disease
Conditions
Interventions
The CRPR diet consists of an estimated 70% of the individuals required calories and 20% of the individuals protein (12), based on the basal metabolic rates and on the daily energy requirements (DER) a
Sponsors
none
Eligibility
Inclusion criteria
Inclusion criteria: - Crohn's disease - Active mild to moderate disease (defined as an endoscopic SES-CD score ≥ 6 or in case of exclusive ileal disease ≥ 4, after ileocoecal resection a Rutgeert's score >i2 and a HBI score between 5 and 10) - Age between 18 ¨C 70 years at baseline
Exclusion criteria
Exclusion criteria: - BMI: 35 - Weight loss of >5% within one month or >10% within 6 months prior to the study - Use of pro- and antibiotics in 6 weeks prior to start of the study - Known allergy/intolerance to any of the ingredients in the diets - Known malignancy or dysplasia - Pregnancy, lactation -Risk of malnutrition as determined by renal insufficiency, renal or electrolyte abnormality (serum creatinine >2x upper limit of normal (ULN); eGFR < 30 mL/min Serum potassium outside the 3,5- 5,0 mmol/l range and serum sodium outside the 135-145 mmol/l range) - Presence of toxins or other signs of infectious agents in stool sample (i.e. clostridium, salmonella, shigella, yersinia or campylobacter) - Insulin-dependent diabetes mellitus - Patients using oxygen and not able to stop for 30 minutes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with clinical remission after 4 weeks of dietary intervention. Clinical remission will be defined as a Harvey Bradshaw Index (HBI) < 5. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Proportion of patients with clinical response. Clinical response will be defined as HBI reduction ≥ 3. - Feasibility; proportion of patients that have maintained the diet throughout the trial period, combined with the compliance. Feasibility will be defined as >70% adherence to the protocol (based on known drug adherence rates in this study group, which is 66%). Compliance to the diet will be assessed by serum (pro)-albumin, urea and retinol binding protein. - Proportion of patients with biochemical remission. Biochemical remission will be defined as CRP ≤10 mg/L and a faecal calprotectin 200≤g/g. - Proportion of patients with relapse of CD (necessitating surgery, (re)introducing biologics, corticosteroids or IS). - Changes in bristol stool scale - Changes in grip strength - Changes in % fat, % free fat mass, fat mass in kg, free fat mass in kg, body mass, body volume and body density as measured by BOD POD- Qualify of life measured by IBDQ - Safety and tolerability of the low caloric low protein diet will be assessed by VAS scores by PROM: PRO-2 (abdominal pain and stool frequency). and adverse events. Molecular markers: - Changes in CRP and faecal calprotectin (FCP) - Changes in molecular factors (leptin, HO-1, GST, H2S) and microbiome. | — |
Outcome results
None listed