Medical Center University of Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
NCT Number: NCT04290429
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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Notify Me18 year–75 year
All sexes
Interventional
Early Phase 1
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Treatment of patients with SR-GI-GVHD with teduglutide
Time frame: 2 years
Quantification of Paneth cell numbers within the intestinal crypts before and during teduglutide treatment.
Time frame: 2 years
Analysis of patient's stool frequency before and during teduglutide treatment.
Time frame: 2 years
Analysis of patient's albumin serum levels before and during teduglutide treatment.
University of Freiburg
Other
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).
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