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. Harvey-Bradshaw index > 4 or frequency of defaecation > 4 / day 2. Serum C-reactive protein >20 (according to the last measurement, measured at most 3 months before the study) 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 30 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 within 3 months before the study 13. Use of steroids, cyclosporine, aTFN compounds, methotrexate, antibiotics or loperamide/codeine 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 within 3 months before the study;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 >20 (according to the last measurement, measured at most 3 months before the study) 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 30 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 within 3 months before the study 14. Use of steroids, cyclosporine, aTFN compounds, methotrexate, antibiotics or loperamide/codeine 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 within 3 months before the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary study endpoint is the difference between Crohn*s patients and disease controls in increase in fasting plasma FGF19 concentration after 8 days CDCA ingestion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study endpoints are the differences between Crohn*s patients and disease controls in: 1. acute increase of fasting plasma FGF19 concentration after CDCA ingestion; 2. increase of fasting gallbladder volumes after acute and 8 days CDCA ingestion; 3. expression in ileal and caecal biopsies of FXR and various target genes after CDCA ingestion; 4. fecal bile salt excretion after CDCA ingestion. | — |
Countries
Netherlands
Outcome results
None listed