Short Bowel Syndrome and Teduglutide Versus Placebo

What Was Tested

In this phase 4 trial, researchers set out to test Teduglutide (GLP-2 analog).

This research study was done to see what the effects are of Teduglutide on people with short bowel syndrome (SBS).

It had two arms (groups): Teduglutide First, then Placebo (experimental) and Placebo First, then Teduglutide (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Subsequently, participants were switched over to the alternate treatment arm for seven days, after a washout period of at least seven days.

Throughout the study participants filled out a food diary and a stool diary (number, consistency, ease of passage) every day.

Women of childbearing potential had a pregnancy test.

Technetium sestamibi (99mTc) pellets were ingested in a scrambled egg, toast, and milk meal (218 kcal) to facilitate measurement of gastric transit.

Who Took Part

The registry lists 8 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Short bowel syndrome. Dependent on parenteral nutrition.

The full record lists 2 inclusion and 17 exclusion criteria; among the exclusions: pregnant, trying to become pregnant or lactating; alcohol or drug abuse within the last year by history; active crohn's disease as evaluated by standard procedures employed by the investigator.

How the Study Was Run

It was run as a randomized, crossover and quadruple-blind study.

The participants were allocated by chance, so the Teduglutide (GLP-2 analog) group and the comparison group should start out alike.

Each person switched between Teduglutide (GLP-2 analog) and the comparison at some point, usually with a gap in between.

As a double-blind Teduglutide (GLP-2 analog) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2014-01 with completion listed for 2015-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Gastric Emptying Half-Time (T1/2) (time frame: approximately 2 hours after radiolabeled meal is ingested). Overall Gut Transit (time frame: baseline, approximately 6 hours after ingestion of radiolabeled meal).

It also tracked 3 secondary outcomes, for example Change in Small Intestinal and Colonic Permeability as Measured by Urinary Excretion of Mannitol, Change in Small Intestinal and Colonic Permeability as Measured by Urinary Excretion of Lactulose at 2 Hours and Change in Small Intestinal and Colonic Permeability as Measured by Lactulose/Mannitol Ratio at 2 Hours.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Teduglutide (GLP-2 analog) in 8 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Teduglutide (GLP-2 analog) compound page, all human trials.