Pilot Study with Treatment of Short Bowel Syndrome Patients with dipeptidyl-peptidase 4 inhibitor, Sitagliptin (Januvia®)

Phase 1

• Conditions: Short Bowel Syndrome with intestinal failure (SBS IF); Therapeutic area: Diseases [C] - Digestive System Diseases [C06]; MedDRA version: 17.1 Level: LLT Classification code 10022683 Term: Intestinal malabsorption System Organ Class: 100000004856; MedDRA version: 17.1 Level: LLT Classification code 10036430 Term: Post surgical malabsorption NOS System Organ Class: 100000004856; MedDRA version: 17.1 Level: LLT Classification code 10042822 Term: Syndrome malabsorption System Organ Class: 100000004856

• Registration Number: EUCTR2014-001941-25-DK
• Lead Sponsor: Rigshospitalet 2121

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-24
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

Patients with intestinal failure and short bowel syndrome and colon in continuation and function and fecal output = 1,5 kg
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 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

Pregnant, disabled and patients with short bowel syndrome and stomi.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: The objective of the trial is to assessthe therapeutic effect of the di-peptidyl-peptidase 4 inhibitor, Sitagliptin (Januvia®) for SBS patients<br> with colon in function. The efficacy is assessed through the ability of<br> sitagliptin (Januvia®) to increase intestinal absorption, reduce diarrhea<br> and the need for hyperphagia.<br> ;<br> Secondary Objective: To test possible biomarkers for determination of intestinal adaptation, p-citrulline,<br> p-paracetamol absorptions test are performed.<br> ;Primary end point(s): Faecal weight/diarrhea;Timepoint(s) of evaluation of this end point: Before and at the end of 8 weeks of treatment with Januvia

Secondary Outcome Measures

Name	Time	Method
<br> 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<br> ;Timepoint(s) of evaluation of this end point: Before and at the end of 8 weeks of treatment with Januvia