DRUG
Teduglutide
Treatment of patients with SR-GI-GVHD with teduglutide
Treatment of Patients With Teduglutide (GLP-2) for GVHD and Analysis of Paneth Cells of GVHD Patients
Status
Completed
Phase
Early Phase 1
Enrollment
6
Locations
1
Results
Not posted
Publications
6
Study summary
What the protocol is testing.
In this study the investigators evaluate the outcomes of six steroid-refractory GVHD patients with gastrointestinal signs of GVHD that were treated with teduglutide.
Full 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
Treatment arms and agents.
Timeline
From registration to results.
First posted
Mar 2, 2020
Study start
Dec 6, 2017
Primary completion
Dec 6, 2019
Study completion
Dec 6, 2019
Results posted
Not reported
Registry updated
Nov 29, 2023
Outcomes
What the study measures.
Primary outcomes
Paneth cell numbers
Time frame · 2 years
Quantification of Paneth cell numbers within the intestinal crypts before and during teduglutide treatment.
Secondary outcomes
Stool frequency
Time frame · 2 years
Analysis of patient's stool frequency before and during teduglutide treatment.
Intestinal absorption
Time frame · 2 years
Analysis of patient's albumin serum levels before and during teduglutide treatment.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Sex
- ALL
- Healthy volunteers
- No
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
Study locations
1 registered sites.
Germany. Showing up to 24 locations stored in the fast local snapshot.
Medical Center University of Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Publications
Results and literature.
PMID 29171820 ↗Zeiser R, Blazar BR. Acute Graft-versus-Host Disease - Biologic Process, Prevention, and Therapy. N Engl J Med. 2017 Nov 30;377(22):2167-2179. doi: 10.1056/NEJMra1609337. No abstract available.PMID 24161075 ↗Drucker DJ, Yusta B. Physiology and pharmacology of the enteroendocrine hormone glucagon-like peptide-2. Annu Rev Physiol. 2014;76:561-83. doi: 10.1146/annurev-physiol-021113-170317. Epub 2013 Oct 25.PMID 8755576 ↗Drucker DJ, Erlich P, Asa SL, Brubaker PL. Induction of intestinal epithelial proliferation by glucagon-like peptide 2. Proc Natl Acad Sci U S A. 1996 Jul 23;93(15):7911-6. doi: 10.1073/pnas.93.15.7911.PMID 11212269 ↗Boushey RP, Yusta B, Drucker DJ. Glucagon-like peptide (GLP)-2 reduces chemotherapy-associated mortality and enhances cell survival in cells expressing a transfected GLP-2 receptor. Cancer Res. 2001 Jan 15;61(2):687-93.PMID 11231933 ↗Jeppesen PB, Hartmann B, Thulesen J, Graff J, Lohmann J, Hansen BS, Tofteng F, Poulsen SS, Madsen JL, Holst JJ, Mortensen PB. Glucagon-like peptide 2 improves nutrient absorption and nutritional status in short-bowel patients with no colon. Gastroenterology. 2001 Mar;120(4):806-15. doi: 10.1053/gast.2001.22555.PMID 22982184 ↗Jeppesen PB, Pertkiewicz M, Messing B, Iyer K, Seidner DL, O'keefe SJ, Forbes A, Heinze H, Joelsson B. Teduglutide reduces need for parenteral support among patients with short bowel syndrome with intestinal failure. Gastroenterology. 2012 Dec;143(6):1473-1481.e3. doi: 10.1053/j.gastro.2012.09.007. Epub 2012 Sep 11.
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