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

Recruitment & Eligibility

Status: Withdrawn

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study endpoints are:<br /><br>1. The differences between Crohn*s patients and controls in bile<br /><br>salt-stimulated increases of fasting gallbladder volumes and fasting FGF19<br /><br>levels;<br /><br>2. The differences in bile salt-induced expression in ileal and cecal biopsies<br /><br>of FXR and various target genes between both groups. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study endpoint are the differences in fecal bile salt excretion after<br /><br>CDCA stimulation between CD patients and controls. </p><br>

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