Treatment of Short Bowel Syndrome Patients with end-jejunostomi with the Glucagon-Like Peptide-1 analogue, Liraglutide (Victoza®)

Conditions: MedDRA version: 16.1Level: LLTClassification code 10042822Term: Syndrome malabsorptionSystem Organ Class: 100000004856
Short Bowel Syndrome with intestinal failure (SBS IF)
MedDRA version: 16.1Level: LLTClassification code 10022683Term: Intestinal malabsorptionSystem Organ Class: 100000004856
MedDRA version: 16.1Level: LLTClassification code 10036430Term: Post surgical malabsorption NOSSystem Organ Class: 100000004856
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2013-005499-16-DK

Lead Sponsor: Rigshospitalet, 2121

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Patients with intestinal failure and short bowel syndrome and a jejunostomy
Age 18 to 90 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 9
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

Pregnant, disabled.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of the trial is to assessthe therapeutic effect of the glucagon-like peptide-1 analogue, liraglutide (Victoza®) for SBS patients with an end-jejunostomi. The efficacy is assessed through the ability of liraglutide (Victoza®) to increase intestinal absorption, reduce diarrhea and the need for hyperphagia, and determine if liraglutide (Victoza®) can reduce the need for parenteral support.;Secondary Objective: To test possible biomarkers for determination of intestinal adaptation. p-citrulline, p-paracetamol absorptions test,;Primary end point(s): Faecal weight/stoma output;Timepoint(s) of evaluation of this end point: Before and at the end of 8 weeks of treatment with Victoza

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Change in:<br>urinary volume<br>oral intake<br>parenteral volume support<br>Fluid composite effect<br>Body weight<br>Body composition (DEXA)<br>Mesenteric blood flow;Timepoint(s) of evaluation of this end point: Before and at the end of 8 weeks of treatment with Victoza