Crohn's disease
Conditions
Interventions
Chenodeoxycholic acid 15 mg/kg.
Sponsors
P.D. Siersema, MD, PhD, Utrecht, The Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: Patients with Crohn’s disease: 1. Surveillance colonoscopy for established Crohn’s disease of the colon (indicated for clinical reasons); 2. Informed consent of the patient. Disease controls: 1. A clinically indicated colonoscopy to exclude significant disease of the colon; 2. Informed consent of the patient.
Exclusion criteria
Exclusion criteria: Patients with Crohn’s disease: 1. HBI score > 4 or frequency of defaecation > 4 / day; 2. Serum C-reactive protein >7 within 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 increased compared to control or activated partial thromboplastin time (APTT) > 9 seconds increased compared to control (these values are considered within the normal range) within 3 months before the study; 13. Use of steroids, cyclosporine, methotrexate, anti-TNF compounds, antibiotics, loperamide/codeine or laxatives within one month before the study; 14. Use of drugs, potentially interfering with CDCA (e.g. ursodeoxycholic acid or bile salt sequestrants), within one month before the study; 15. Pregnancy or lactation; 16. Liver function disorders: ASAT, ALAT, LDH, gGT and/or AF increased above ULN 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 >7 within 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 increased compared to control or partial thromboplastin time (PTT) > 9 seconds compared to control (these values are considered normal) within 3 months before the study; 14. Use of steroids, cyclosporine, methotrexate, anti-TNF compounds, antibiotics, loperamide/codeine or laxatives within one month before the study; 15. Use of drugs, potentially interfering with CDCA (e.g. ursodeoxycholic acid or bile salt sequestrants), within one month before the study; 16. Pregnancy or lactation; 17. Liver function disorders: ASAT, ALAT, LDH, gGT, and/or AF increased above ULN 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 of 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. | — |
Contacts
Public ContactFiona D.M. Schaik, van
Department of Gastroenterology and Hepatology, F02.618 University Medical Center Utrecht P.O. Box 85500
Outcome results
None listed