Chronic Intestinal Inflammation Crohn's disease
Conditions
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Colonoscopy clinically indicated to exclude significant disease of the colon or surveillance colonoscopy for Crohn's disease of the colon; 2. Informed consent of the patient.
Exclusion criteria
Exclusion criteria: Patients with Crohn*s disease: 1. CDAI > 150 or frequency of defaecation > 4 / day 2. Serum C-reactive protein >7 3. Surgery of the gastro-intestinal tract (only appendectomy is allowed) 4. Previous cholecystectomy 5. Gallbladder or bile duct stones 6. Previous ERCP with papillotomy. 7. Age 25 10. Concomitant primary sclerosing cholangitis or other significant hepatic or biliary pathology 11. Any malignancy within 5 years before the study 12. Clotting disorders: prolonged prothrombin time (PT) > 2.5 seconds or partial thromboplastin time (PTT) > 9 seconds 13. Use of steroids, cyclosporine, aTFN compounds, methotrexate, antibiotics, loperamide/codeine or laxatives within one month before the study 14. Use of drugs, potentially interfering with CDCA (e.g. colestyramine, ursodeoxycholic acid or bile salt questrants), within one month before the study 15. Pregnancy or lactation 16. Liver function disorders: increased ASAT, ALAT, LDH, gGT and/or AF in relation to the upper limit of normal ;Disease controls: 1. Previous inflammation of the gastrointestinal tract (excluding previous infectious gastroenteritis if>6 months ago) 2. Frequency of defaecation > 4 / day 3. Serum C-reactive protein >7 4. Surgery of the gastro-intestinal tract (only appendectomy is allowed) 5. Previous cholecystectomy 6. Gallbladder or bile duct stones 7. Previous ERCP with papillotomy. 8. Age 25 11. Concomitant primary sclerosing cholangitis, or other significant hepatic or biliary pathology 12. Any malignancy within 5 years before the study 13. Clotting disorders: prolonged prothrombin time (PT) > 2.5 seconds or partial thromboplastin time (PTT) > 9 seconds 14. Use of steroids, cyclosporine, aTFN compounds, methotrexate, antibiotics, loperamide/codeine or laxatives within one month before the study 15. Use of drugs, potentially interfering with CDCA (e.g. colestyramine, ursodeoxycholic acid or bile salt questrants), within one month before the study 16. Pregnancy or lactation 17. Liver function disorders: increased ASAT, ALAT, LDH, gGT, AF in relation to the upper limit of normal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary study endpoints are: 1. The differences between Crohn*s patients and controls in bile salt-stimulated increases of fasting gallbladder volumes and fasting FGF19 levels; 2. The differences in bile salt-induced expression in ileal and cecal biopsies of FXR and various target genes between both groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study endpoint are the differences in fecal bile salt excretion after CDCA stimulation between CD patients and controls. | — |
Countries
Netherlands
Outcome results
None listed