(Patho)Physiological aspects of the bile salt-FXR-FGF19 axis: potential consequences in Crohn’s disease.
- Conditions
- Crohn's disease
- Registration Number
- NL-OMON27642
- Lead Sponsor
- P.D. Siersema, MD, PhD, Utrecht, The Netherlands
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
Patients with Crohn’s disease:
1. Surveillance colonoscopy for established Crohn’s disease of the colon (indicated for clinical reasons);
Exclusion Criteria
Patients with Crohn’s disease:
1. HBI score > 4 or frequency of defaecation > 4 / day;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary study endpoints are the differences between Crohn’s patients and 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 ingestion;<br /> <br>3. Expression in ileal and caecal biopsies of FXR and various target genes after CDCA ingestion;<br /> <br>4. Fecal bile salt excretion after CDCA ingestion.