Pilot Study to Investigate the Effect of Teduglutide on Temporary Ileostomy Function and Complications

What Was Tested

The trial (phase 3) is built around Teduglutide (GLP-2 analog).

It had two arms (groups): Teduglutide (active comparator) and Placebo (placebo comparator).

Placebo.

The registry classes the interventions as drug.

More on the Plan

This is a prospective, controlled, randomized, double blind study.

A total of 36 subjects will be enrolled into the study.

Subjects will be randomized to receive Teduglutide or Placebo for 12 weeks or until the ileostomy is reversed.

Teduglutide or placebo will be administered via a daily subcutaneous injection into the abdomen or thigh.

Who Took Part

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Patients who are undergoing temporary ileostomy (loop or end ileostomy) regardless of the indication or technique used (open or laparoscopy) as part of their regular standard of care. Age- 18-80 years old. Normal routine laboratories (CMP, CBC, CRP, amylase, lipase).

The full record lists 4 inclusion and 13 exclusion criteria; among the exclusions: emergency need for ileostomy; pregnant or nursing; malnutrition or requiring parenteral or enteral nutrition.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

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

The Teduglutide (GLP-2 analog) group and the comparison group ran side by side rather than switching.

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 and investigator.

It started in 2022-06-02 with completion listed for 2022-11-25.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in daily 24 hr ileostomy collection (time frame: Change from time of surgery to 12 weeks).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Teduglutide (GLP-2 analog) in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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