in Vivo TICE (TransIntestinal Cholesterol Excretion)

Not Applicable

• Conditions: Occlusion of Bile Duct With an External Bile Diversion.

• Registration Number: NCT01958216
• Lead Sponsor: Nantes University Hospital

Brief Summary

So far, the liver has been the main target for cholesterol elimination. However, several recent studies performed in mice have described a new route of cholesterol excretion, the Trans-Intestinal Cholesterol Excretion or TICE. TICE allows direct elimination of plasma cholesterol in the feces directly via the intestine. Until now, only indirect evidence suggests that TICE is also active in humans, the goal of this proof of concept study is to provide the first proof of its existence in humans by using stable isotopes in patients with bile duct diversion.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-09
• Study Start: 2013-09
• Study First Submitted: 2013-09-30
• Study First Submitted QC: 2013-10-08
• Last Update Submitted: 2013-10-08
• Study First Posted: 2013-10-09
• Last Update Posted: 2013-10-09
• Primary Completion: 2015-04
• Study Completion: 2015-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• External bile duct diverted patients

Exclusion Criteria

• Inflammatory bowel disease
• Aphagia
• Renal or hepatocellular insufficiency
• Primary intestinal tumor
• Cholangitis or severe sepsis
• Acute or chronic diarrhea

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Measuring trans-intestinal cholesterol excretion in vivo in bile diverted patients	Day 3	Measuring trans-intestinal cholesterol excretion in vivo in bile diverted patients

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Nantes, France