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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2013-005499-16-DK
Enrollment
Unknown
Registered
2014-01-24
Start date
2014-01-31
Completion date
Unknown
Last updated
2014-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Short Bowel Syndrome with intestinal failure (SBS IF) MedDRA version: 16.1 Level: LLT Classification code 10022683 Term: Intestinal malabsorption System Organ Class: 100000004856 MedDRA version: 16.1 Level: LLT Classification code 10036430 Term: Post surgical malabsorption NOS System Organ Class: 100000004856 MedDRA version: 16.1 Level: LLT Classification code 10042822 Term: Syndrome malabsorption System Organ Class: 100000004856

Interventions

Trade Name: Victoza Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: LIRAGLUTIDE CAS Number: 204656-20-2 Concentration unit: mg milligram(s) Concentration type: r

Sponsors

Rigshospitalet, 2121
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: Pregnant, disabled.

Design outcomes

Primary

MeasureTime frame
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

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

Countries

Denmark

Contacts

Public ContactPalle Bekker Jeppesen

Rigshospitalet, 2121

bekker@dadlnet.dk+4520481323

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026