Short Bowel Syndrome and Teduglutide VS Placebo

Overview

About this study

Investigator plans to examine the gastrointestinal (GI) physiologic profile of Teduglutide, a Glucagon-like Peptide 2 Analog as a possible intestinotrophic growth factor capable of inducing small bowel adaptation and regeneration in patients with short bowel syndrome (SBS), with the potential to decrease parenteral nutrition dependence.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Exclusion criteria for participants

  • 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 Infliximab, growth hormone or growth factors such as native GLP-2 or other biological therapy within the last 12 weeks.
  • Use of Methotrexate, Cyclosporine, Tacrolimus, Sirolimus, Octreotide, intravenous glutamine or 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 GFR [eGFR] <30 ml/min).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Michael Camilleri, M.D.

Closed for enrollment

More information

Publications

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Study Results Summary

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Supplemental Study Information

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Additional contact information

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