Phase 4 N=8 Randomized Quadruple-blind Treatment

Short Bowel Syndrome and Teduglutide Versus Placebo

Short Bowel Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT02099084 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2016

Primary outcome: Primary: Gastric Emptying Half-Time (T1/2) — 113; 106 minutes — p=0.74

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Teduglutide (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Mayo Clinic
Primary completion: Mar 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Gastric Emptying Half-Time (T1/2)	113; 106	0.74
PRIMARY Overall Gut Transit	53.4; 62.4	0.075
SECONDARY Change in Small Intestinal and Colonic Permeability as Measured by Urinary Excretion of Mannitol	16.2; 11.3; 48.8; 32.7	0.20
SECONDARY Change in Small Intestinal and Colonic Permeability as Measured by Urinary Excretion of Lactulose at 2 Hours	0.42; 0.38	—
SECONDARY Change in Small Intestinal and Colonic Permeability as Measured by Lactulose/Mannitol Ratio at 2 Hours	0.024; 0.021	—

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.

Eligibility Criteria

Inclusion criteria

Short bowel syndrome
Dependent on parenteral nutrition

Exclusion criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02099084). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.