TED_ORG: Study on Short Bowel Syndrome

What Was Tested

In this not phased trial, researchers set out to test Teduglutide (GLP-2 analog).

The goal of this clinical trial is to understand why pediatric patients with short bowel syndrome respond differently to treatment with the glucagon-like peptide-2 (GLP-2) analogue teduglutide.

It had two arms (groups): teduglutide-treated organoids (other) and Untreated organoids (other).

Human intestinal organoids derived from pediatric patients with short bowel syndrome are treated in vitro with teduglutide to assess its effects on intestinal morphology, gene and protein expression, and nutrient absorption.

Human intestinal organoids derived from pediatric patients with short bowel syndrome are maintained in vitro without exposure to teduglutide and serve as a control group for comparison.

The registry classes the interventions as drug and other.

Who Took Part

The registry lists 50 planned participants were the target.

It was open to people of any sex aged from 4 months up to 17 years.

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

Examples of who could join: Patients or His/her Parents/ legal guardian must provide informed consent before they can participate in the study. Paediatric patients: Male and female patients aged ≥ 4 months old and ≤ 18 years;. SBS patient or patient undergoing intestinal resective surgery.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: adult patients (≥ 18 years old);; patients who have never undergone intestinal resective surgery; current or past use of teduglutide.

How the Study Was Run

It was run as a non-randomized, single-group and open-label study.

Being open-label, the Teduglutide (GLP-2 analog) study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2024-10-30 with completion listed for 2026-03.

It ran at 1 site in Italy.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Intestinal organoid diameter after in vitro exposure to teduglutide (time frame: During in vitro treatment period (up to 7 days)). Crypt-villus-like architecture in intestinal organoids (time frame: During in vitro treatment period (up to 7 days)). Organoid shape (sphericity) after in vitro teduglutide treatment (time frame: During in vitro treatment period (up to 7 days)).

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Teduglutide (GLP-2 analog) in 50 people.

It is still recruiting; 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.