Overview

This trial is active, not recruiting.

Condition short bowel syndrome
Treatments teduglutide, placebo
Phase phase 4
Sponsor Mayo Clinic
Start date January 2014
End date March 2015
Trial size 8 participants
Trial identifier NCT02099084, 13-004866

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Qualifying participants will be assigned to 2 different treatment arms consisting of placebo or Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days. Subsequently, participants will switch over to alternate treatment arm. In both arms participant will undergo a series of measurements, including 8 hour GI transit, permeability measurements by using mannitol and lactulose, and 8 hour urine and stool collections.
teduglutide
Qualifying participants will be assigned to 2 different treatment arms consisting of placebo or Teduglutide 0.05 mg/kg/d administered subcutaneously. Subsequently, participants will switch over to alternate treatment arm. in both arms participant will undergo a series of measurements including 8 hour GI transit, permeability measurements by using mannitol and lactulose, and 8 hour urine and stool collection.
(Placebo Comparator)
Qualifying participants will be assigned to 2 different treatment arms consisting of placebo or Teduglutide 0.05 mg/kg/d injected subcutaneously for 7 days. Subsequently, participants will switch over to the alternate treatment arm. In both arms participants will undergo a series of measurements including 8 hour GI transit, permeability measurements by using mannitol and lactulose, and 8 hour urine and stool collections.
placebo
Qualifying participants will be assigned to 2 different treatment arms consisting of placebo or Teduglutide 0.05 mg/kg/d administered subcutaneously. Subsequently, participants will switch over to alternate treatment arm. in both arms participant will undergo a series of measurements including 8 hour GI transit, permeability measurements by using mannitol and lactulose, and 8 hour urine and stool collection.

Primary Outcomes

Measure
Change in gastrointestinal transit and measurement of intestinal permeability to lactulose with Teduglutide compared to placebo.
time frame: Post 7 day treatment in both arms with a 14 day washout period between both treatment arms.

Secondary Outcomes

Measure
Measurement of intestinal permeability to mannitol with Teduglutide compared to placebo.
time frame: Post 7 day treatment in both arms with a 14 day washout period between both treatment arms.

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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 6 months (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 SplendaTM (sucralose), NutrasweetTM (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.

Additional Information

Official title Acute Effects of a Glucagon-like Peptide 2 Analog, Teduglutide, on Gastrointestinal Motor Function and Permeability in Patients With Short Bowel Syndrome on Home Parenteral Nutrition
Principal investigator Michael Camilleri, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Mayo Clinic.