Treatment of Patients With Teduglutide (GLP-2) for GVHD and Analysis of Paneth Cells of GVHD Patients

What Was Tested

In this early phase 1 trial, researchers set out to test Teduglutide (GLP-2 analog).

In this study the investigators evaluate the outcomes of six steroid-refractory GVHD patients with gastrointestinal signs of GVHD that were treated with teduglutide.

It had 1 arm (groups): SR-GI-GVHD (experimental).

Analysis of patient's stool frequency, albumin serum levels and quantification of Paneth cell numbers in GI biopsies before and during teduglutide treatment.

The registry classes the interventions as drug.

More on the Plan

It induces positive effects in the GI tract like nutrient uptake, mucosal growth, protection from inflammation, etc.

The investigators will determine the outcome of each patient by monitoring the gastrointestinal signs like diarrhea frequency, intestinal absorption measured by serum-albumin concentrations and GI histology, specifically the number of Paneth cells before and during teduglutide treatment.

Who Took Part

The registry lists 6 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: Patients with signs of acute SR-GI-GVHD. Age ≥ 18 years. Peripheral blood and stool samples available before and during treatment. Written informed consent. Ability to understand the nature of the study and the study related procedures and to comply with them.

The full record lists 5 inclusion and 2 exclusion criteria; among the exclusions: age ≤ 18 years; lack of informed consent.

How the Study Was Run

The set-up was single-group and open-label.

Nothing was hidden in this open-label Teduglutide (GLP-2 analog) study: the participants and staff both knew the treatment.

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

It started in 2017-12-06 with completion listed for 2019-12-06.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Paneth cell numbers (time frame: 2 years).

It also tracked 2 secondary outcomes, for example Stool frequency and Intestinal absorption.

What This Means in Plain Language

Put simply, this is a early phase 1 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; 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.