Short Bowel Syndrome and Teduglutide Versus Placebo
Condition: Short Bowel Syndrome
MeSH terms: Short Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Short bowel syndrome (SBS) refers to the anatomical and/or functional decrease in small
      intestinal absorptive capacity, mostly caused by extensive intestinal resections. The
      decrease in intestinal absorptive capacity leads to malabsorption causing malnutrition,
      dehydration and weight loss, all of which severely impact patient's quality of life.

      In this study, qualifying participants were assigned to 2 different treatment arms consisting
      of placebo or Teduglutide 0.05 mg/kg subcutaneously daily for seven days. Subsequently,
      participants were switched over to the alternate treatment arm for seven days, after a
      washout period of at least seven days. In both arms, after six days of treatment or placebo,
      participants underwent a series of measurements during day 7 of treatment, including 8 hour
      GI transit, permeability measurements by using mannitol and lactulose (0-2h, 2-8h
      collections), and 8 hour urine and stool collections for measurement of volume. Throughout
      the study participants filled out a food diary and a stool diary (number, consistency, ease
      of passage) every day.

      On day 7 of each intervention period participants arrived in the clinical research unit after
      having fasted for at least 8 hours. Women of childbearing potential had a pregnancy test.
      Participants then received their seventh dose of placebo or Teduglutide (1 dose, 1 hour
      before breakfast). Technetium sestamibi (99mTc) pellets were ingested in a scrambled egg,
      toast, and milk meal (218 kcal) to facilitate measurement of gastric transit. All subjects
      received a standard 550 kcal meal at 4 hours (chicken meal) after the radiolabeled meal.
    

Intervention name(s): Teduglutide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive Teduglutide 0.05 mg/kg/d administered subcutaneously.; Participants will receive placebo matching study drug, administered subcutaneously.
Other intervention name(s): Gattex; Revestive
Intervention MeSH terms: Teduglutide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment