Short Bowel Syndrome and Teduglutide Versus Placebo

Completed · Phase 4 · Has a placebo group

Conditions studied: Short Bowel Syndrome

In brief

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.

Key facts

Study ID

NCT02099084

Run by

Mayo Clinic

People needed

8

Starts

2014-01-01

Expected to finish

2015-03-01

Last updated by the study team

2016-02-22

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Short bowel syndrome
• Dependent on parenteral nutrition

You may not qualify if…

• 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.

Where it is running

• Mayo Clinic in Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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