Short Bowel Syndrome and Teduglutide VS Placebo

Overview

Información sobre este estudio

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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).

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Michael Camilleri, M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available
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CLS-20112088

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