Treatment of Patients With Teduglutide (GLP-2) for GVHD and Analysis of Paneth Cells of GVHD Patients
- Registration Number
- NCT04290429
- Lead Sponsor
- University of Freiburg
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
- 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
- Age ≤ 18 years
- Lack of informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SR-GI-GVHD Teduglutide Analysis of patient's stool frequency, albumin serum levels and quantification of Paneth cell numbers in GI biopsies before and during teduglutide treatment.
- Primary Outcome Measures
Name Time Method Paneth cell numbers 2 years Quantification of Paneth cell numbers within the intestinal crypts before and during teduglutide treatment.
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Medical Center University of Freiburg
🇩🇪Freiburg, Baden Württemberg, Germany