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

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).

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04290429

Enrollment

Registered

2020-03-02

Start date

2017-12-06

Completion date

2019-12-06

Last updated

2023-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graft Versus Host Disease

Brief summary

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

Detailed description

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.

Interventions

DRUGTeduglutide

Treatment of patients with SR-GI-GVHD with teduglutide

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Paneth cell numbers	2 years	Quantification of Paneth cell numbers within the intestinal crypts before and during teduglutide treatment.

Secondary

Measure	Time frame	Description
Stool frequency	2 years	Analysis of patient's stool frequency before and during teduglutide treatment.
Intestinal absorption	2 years	Analysis of patient's albumin serum levels before and during teduglutide treatment.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026