Effects of Oral Citrulline on Protein Metabolism in Patients With Intestinal Failure (Citrugrêle 2) (CITRUGRELE 2)

Nantes University Hospital (NUH)

Status and phase

Completed

Phase 3

Conditions

Intestinal Failure

Treatments

Drug: Citrulline and placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01386034

BRD/09/05-W

Details and patient eligibility

About

The specific aim of this study is to determine whether oral citrulline administration enhances whole body protein synthesis in patients with intestinal failure. Protein metabolism will be assessed using an intravenous infusion of stable isotope labeled leucine. The investigators hypothesize that citrulline supplementation will decrease leucine oxidation without altering proteolysis, and consequently stimulate protein synthesis.

Enrollment

11 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult between 18 and 75 years
Patient with short bowel syndrome
Patient with an incompetent small intestine after intestinal resection
Patient fed orally and beyond more than 6 weeks after surgery
Absence of any earlier supplementation with citrulline, glutamine, ornithine a-ketoglutarate, or stimol®
No current artificial feeding (parenteral)
No low-sodium diet- No renal, cardiac, respiratory or hepatic insufficiency
No chronic inflammatory disease (intestinal or other)
No current corticosteroid treatment
Fasting blood glucose below 6mmol/L
Patient able to understand benefits and risks of protocol
Women who are of childbearing potential must have a negative serum pregnancy test and agree to use a medically acceptable method of contraception throughout the study and for 15 days following the end of the study
Signed informed consent