(Patho)Physiological aspects of the bile salt-FXR-FGF19-axis: potential consequences in Crohn's disease.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 24

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

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 < 18 years
8. Inability to communicate with the patient
9. Body Mass Index > 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 < 18 years
9. Inability to communicate with the patient
10. Body Mass Index > 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study endpoint is the difference between Crohn*s patients and disease<br /><br>controls in increase in fasting plasma FGF19 concentration after 8 days CDCA<br /><br>ingestion.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study endpoints are the differences between Crohn*s patients and<br /><br>disease controls in:<br /><br>1. acute increase of fasting plasma FGF19 concentration after CDCA ingestion;<br /><br>2. increase of fasting gallbladder volumes after acute and 8 days CDCA<br /><br>ingestion;<br /><br>3. expression in ileal and caecal biopsies of FXR and various target genes<br /><br>after CDCA ingestion;<br /><br>4. fecal bile salt excretion after CDCA ingestion. </p><br>

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