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

Study Overview
=================
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.

Official 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).

Conditions
-----------------
Graft Versus Host Disease

Intervention / Treatment
-----------------
* Drug: Teduglutide


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SR-GI-GVHD<br>Analysis of patient's stool frequency, albumin serum levels and quantification of Paneth cell numbers in GI biopsies before and during teduglutide treatment. | Drug: Teduglutide<br>* Treatment of patients with SR-GI-GVHD with teduglutide<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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