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Completed

NCT Number: NCT04290429

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

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Medical Center University of Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

About this study

Preliminary studies have showed that Glucagon-like peptide 2 (GLP-2) has regenerative and protective effects on the gastrointestinal tract after bowel injury. It induces positive effects in the GI tract like nutrient uptake, mucosal growth, protection from inflammation, etc. One of the target organs from GVHD is the GI tract, and since patients suffering from GI-GVHD experience intestinal disorders like loss of mucosal epithelial integrity, diarrhea accompanied by strong abdominal pain that can lead to food inanition, the investigators therefore aimed to examine the outcome of patients suffering from SR-GI-GVHD that are treated with the GLP-2 analogue, Teduglutide. 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 can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Age ≤ 18 years
  • Lack of informed consent

Treatment and study plan

Teduglutide

Drug

Treatment of patients with SR-GI-GVHD with teduglutide

Primary outcomes

  1. Paneth cell numbers

    Time frame: 2 years

    Quantification of Paneth cell numbers within the intestinal crypts before and during teduglutide treatment.

Secondary outcomes

  1. Stool frequency

    Time frame: 2 years

    Analysis of patient's stool frequency before and during teduglutide treatment.

  2. Intestinal absorption

    Time frame: 2 years

    Analysis of patient's albumin serum levels before and during teduglutide treatment.

Sponsors and collaborators

Lead sponsor

University of Freiburg

Other

Registry information

Official study title

Analysis of the Effect of Teduglutide Treatment on Intestinal Malabsorption and Paneth Cell Numbers in Patients With Steroid-refractory Gastrointestinal Graft Versus Host Disease (SR-GI-GVHD).

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 2, 2020
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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