Short Bowel Syndrome and Teduglutide Versus Placebo
Condition: Short Bowel Syndrome
MeSH terms: Short Bowel Syndrome; Syndrome
Intervention: Teduglutide; Placebo
Intervention description: Participants will receive Teduglutide 0.05 mg/kg/d administered subcutaneously.; Participants will receive placebo matching study drug, administered subcutaneously.
Intervention MeSH terms: Teduglutide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This research study was done to see what the effects are of Teduglutide on people with short
      bowel syndrome (SBS). Teduglutide is a synthetic medication administered as an injection,
      which has shown to increase intestinal blood flow, inhibit gastric secretion, increase growth
      of intestinal cells and increase absorption of nutrients. Teduglutide has demonstrated to
      decrease Total Parenteral Nutrition (TPN) requirements by 20%. Teduglutide is approved by the
      Food and Drug Administration (FDA) for the treatment of adult patients with Short Bowel
      Syndrome (SBS) who are dependent on parenteral support.

      The primary hypotheses for this study were 1) that Teduglutide significantly increases the
      gastric emptying half time of solids when compared to placebo. 2) Teduglutide will
      significantly decrease the intestinal permeability and urinary excretion of lactulose when
      compared to placebo.
    

Eligibility criteria:

        Inclusion criteria:

          -  Short bowel syndrome

          -  Dependent on parenteral nutrition

        Exclusion criteria:

          -  Pregnant, trying to become pregnant or lactating

          -  Diabetes

          -  Alcohol or drug abuse within the last year by history

          -  Active Crohn's disease as evaluated by standard procedures employed by the
             investigator

          -  History of radiation enteritis, scleroderma, celiac disease, tropical sprue, diabetes,
             chronic pseudo-obstruction or malignancies

          -  Previous use of Teduglutide or potential allergies to Teduglutide or its constituents

          -  Any hospitalization within 1 month before screening

          -  Use of Octreotide, intravenous glutamine growth hormone or growth factors such as
             native Glucagon-like Peptide 2 (GLP-2) within the last 12 weeks

          -  Infliximab or other biological agents, Azathioprine, Methotrexate, Cyclosporine,
             Tacrolimus, Sirolimus, should be stable for at least 8 weeks prior to baseline and
             remain stable during the study

             - Any investigational drug within last 30 days

          -  Diuretics and oral rehydration solutions will be required to be stable for ≥4 weeks
             prior to baseline evaluations and remain stable during the study

          -  Change in dose of antimotility or secretory agents from 2 days prior to, and
             throughout the two phases and washout periods of the study

          -  Use of tobacco products within the prior 1 month (since nicotine can affect
             permeability)

          -  Use of NSAIDS or aspirin within the past week

          -  Use of oral corticosteroids within the previous 6 weeks

          -  Ingestion of artificial sweeteners such as Splenda (sucralose), Nutrasweet
             (aspartame), lactulose or mannitol 2 days each of the study measurement days, e.g.,
             foods to be avoided are sugarless gums or mints and diet soda

          -  History of pancreatitis

          -  Primary renal impairment (estimated glomerular filtration rate (eGFR)) <30 ml/min.