Teduglutide for Enterocutaneous Fistula (ECF)

What Was Tested

This registered phase 2 trial tested Teduglutide (GLP-2 analog).

It had two arms (groups): Standard of Care followed by Teduglutide (experimental) and Teduglutide followed by Standard of Care (experimental).

Participants in this group will receive standard of care treatment for the first 8 weeks followed by daily Teduglutide for the next 8 weeks. Subjects with a favorable response will be offered an open label extension during which they will continue to receive teduglutide for up to another 12 months or permanent fistula closure.

Participants in this group will receive daily Teduglutide treatment for the first 8 weeks followed by standard of care for the next 8 weeks. Subjects with a favorable response will be offered an open label extension during which they will continue to receive teduglutide for up to another 12 months or permanent fistula closure.

The registry classes the interventions as drug and other.

Who Took Part

The registry lists 6 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Enterocutaneous fistula (ECF) that could be secondary to volvulus, injury, prior trauma or surgery, or vascular ischemia.

The full record lists 2 inclusion and 18 exclusion criteria; among the exclusions: perianal fistula; clinical suspicion of inflammatory bowel disease; history of radiation enteritis or sprue (as defined by history).

How the Study Was Run

Design: randomized, crossover and single-blind.

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.

In this single-blind Teduglutide (GLP-2 analog) study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2019-01-31 with completion listed for 2020-07-15.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Average 3-day Fistula Percent Volume (time frame: Baseline, Up to 8 weeks).

It also tracked 8 secondary outcomes, for example Number of Participants With Ceased Fistula Output, Quality of Life as Measured by ASCQ-Me® v2.0 Social Functioning - Short Form, Quality of Life as Measured by the ASCQ-Me® v2.0 Sleep Impact - Short Form, Quality of Life as Measured by the PROMIS Scale v1.2 - Global Health, Quality of Life as Measured by the PROMIS Scale v1.0 - Gastrointestinal Belly Pain 5a and Quality of Life as Measured by the PROMIS Scale v1.0 - Gastrointestinal Diarrhea 6a.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Teduglutide (GLP-2 analog) in 6 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.