Primary outcomeMean· approximately 2 hours after radiolabeled meal is ingested
Gastric Emptying Half-Time (T1/2)
| Group | Value (minutes) | Spread |
|---|---|---|
| Teduglutide | 113 | 16 |
| Placebo | 106 | 20 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataShort Bowel Syndrome and Teduglutide Versus Placebo
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 8 participants (actual)
- Sponsor
- Mayo Clinic · Other
- Design
- Randomized · Quadruple masking
- Countries
1 country
United States
- Start
- Jan 2014
- Primary completion
- Mar 2015
- Completion
- Mar 2015
- First posted
- 28 Mar 2014 (estimated)
- Last update posted
- 22 Feb 2016 (estimated)
- Conditions
- Short Bowel Syndrome
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201420152016
- Ph 4
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- TeduglutideDrug
- PlaceboDrug
Arms2
Experimental
Teduglutide First, then Placebo
Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days, followed by a 14-day washout period, and placebo administered subcutaneously for 7 days.
Placebo comparator
Placebo First, then Teduglutide
Placebo administered subcutaneously for 7 days, followed by a 14-day washout period, and Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days.
Primary outcomes2
Outcomes the sponsor listed as primary.
Gastric Emptying Half-Time (T1/2)
Time frame · approximately 2 hours after radiolabeled meal is ingested
Registry description
The time for half of the ingested solids or liquids to leave the stomach.
Overall Gut Transit
Time frame · baseline, approximately 6 hours after ingestion of radiolabeled meal
Registry description
Given the variable extent of the residual length of the small intestine and colon, the proportion emptied from the body at 6 hours was assessed as an overall estimate of the whole gut transit. The 6-hour values for intra-abdominal counts were then compared with the 100% reference values of counts (at time zero, which is immediately after ingestion of the radiolabeled meal) to determine the percentage of isotope retained in the abdomen. 100% minus the percentage of retained isotope reflected the amount emptied from the GI tract.
Secondary outcomes(3)
Change in Small Intestinal and Colonic Permeability as Measured by Urinary Excretion of Mannitol
Time frame · baseline, approximately 2 hours and 8 hours after ingestion of radiolabeled meal
Registry description
Permeability is measured through differential excretion of urine saccharides. A sugar solution (200 mg of mannitol and 1 g lactulose in 30 mL of water) was administered with the radiolabeled test meal at visits 1 and 2. Urine was collected during 0-2 and 2-8 hours. A baseline urine sample was also collected prior to ingestion of the sugars. Chemical analysis was preformed with high-speed liquid chromatography tandem mass spectrometry.
Change in Small Intestinal and Colonic Permeability as Measured by Urinary Excretion of Lactulose at 2 Hours
Time frame · baseline, approximately 2 hours after ingestion of radiolabeled meal
Registry description
Permeability is measured through differential excretion of urine saccharides. A sugar solution (200 mg of mannitol and 1 g lactulose in 30 mL of water) was administered with the radiolabeled test meal at visits 1 and 2. Urine was collected during 0-2 and 2-8 hours. A baseline urine sample was also collected prior to ingestion of the sugars. Chemical analysis was preformed with high-speed liquid chromatography tandem mass spectrometry.
Change in Small Intestinal and Colonic Permeability as Measured by Lactulose/Mannitol Ratio at 2 Hours
Time frame · baseline, approximately 2 hours after ingestion of radiolabeled meal
Registry description
Permeability is measured through differential excretion of urine saccharides. A sugar solution (200 mg of mannitol and 1 g lactulose in 30 mL of water) was administered with the radiolabeled test meal at visits 1 and 2. Urine was collected during 0-2 and 2-8 hours. A baseline urine sample was also collected prior to ingestion of the sugars. Chemical analysis was preformed with high-speed liquid chromatography tandem mass spectrometry.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeMean· baseline, approximately 6 hours after ingestion of radiolabeled meal
Overall Gut Transit
| Group | Value (Percentage of isotope emptied) | Spread |
|---|---|---|
| Teduglutide | 53.4 | 15 |
| Placebo | 62.4 | 15.2 |
Secondary and other outcome results(5)
Secondary outcomeMean· baseline, approximately 2 hours and 8 hours after ingestion of radiolabeled meal
Change in Small Intestinal and Colonic Permeability as Measured by Urinary Excretion of Mannitol
| Group | Value (mg) | Spread |
|---|---|---|
| Teduglutide | 16.2 | 3.6 |
| Placebo | 11.3 | 2.2 |
Secondary outcomeMean· baseline, approximately 2 hours after ingestion of radiolabeled meal
Change in Small Intestinal and Colonic Permeability as Measured by Urinary Excretion of Lactulose at 2 Hours
| Group | Value (mg) | Spread |
|---|---|---|
| Teduglutide | 0.42 | 0.14 |
| Placebo | 0.38 | 0.14 |
Secondary outcomeMean· baseline, approximately 2 hours after ingestion of radiolabeled meal
Change in Small Intestinal and Colonic Permeability as Measured by Lactulose/Mannitol Ratio at 2 Hours
| Group | Value (ratio) | Spread |
|---|---|---|
| Teduglutide | 0.024 | 0.005 |
| Placebo | 0.021 | 0.005 |
Other pre specified outcomeMean· approximately 8 hours after ingestion of radiolabeled meal
Stool Weight at 8 Hours
| Group | Value (g) | Spread |
|---|---|---|
| Teduglutide | 77 | 18 |
| Placebo | 106 | 43 |
Other pre specified outcomeMean· Start of the ingestion of the radiolabeled meal until 8 hours after the meal
Urine Volume at 8 Hours
| Group | Value (mL) | Spread |
|---|---|---|
| Teduglutide | 408.9 | 52.2 |
| Placebo | 365.7 | 57.3 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| TeduglutideTeduglutide 0.05 mg/kg/d administered subcutaneously for 7 days in either first intervention period or second intervention period | – | 0 / 8 | 2 / 8 |
| PlaceboPlacebo administered subcutaneously daily for 7 days in either first intervention period or second intervention period | – | 0 / 8 | 1 / 8 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies1
Studies that cite this trial.
Studies with results
1 study on this page
Indexing hint: Randomized controlled trial · 2016
8 results
Acute Effects of a Glucagon-Like Peptide 2 Analogue, Teduglutide, on Gastrointestinal Motor Function and Permeability in Adult Patients With Short Bowel Syndrome on Home Parenteral Nutrition.
Iturrino et al. 2016JPEN. Journal of parenteral and enteral nutritioncited by 29
PMID 26223941DOI 10.1177/0148607115597644PUB-26223941
Full text at the publisher8 results
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 75 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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.
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