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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04522843
Other study ID # GVHD_Def
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 1, 2018
Est. completion date December 31, 2024

Study information

Verified date August 2023
Source University of Freiburg
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study has the aim to analyze intestinal expression of endogenous antimicrobial peptides in patients with acute GVHD. The expression will be compared to intestinal expression of defensins in patients with colitis and patients without intestinal inflammation.


Description:

Acute graft-versus-host disease (GVHD) is a major cause of morbidity and mortality in patients undergoing allogeneic hematopoietic cell transplantation (allo-HCT). Acute GVHD is characterized by complex deficiencies of the mucosal antimicrobial barrier and intestinal dysbiosis, which contribute to disease pathogenesis. Defensins are endogenous epithelial cell-derived antimicrobial peptides, which can protect epithelial barrier integrity, shape the intestinal microbiota composition and contribute to host immunoregulation. Deregulated expression of defensins has been reported in patients with colitis, including Chron's Disease and ulcerative colitis. In this study, the investigators aim to analyze the expression of defensins in the intestine of patients with acute GVHD to study whether it is deregulated. The results will be valuable to study the role of defensins during acute GVHD pathogenesis or as potential biomarkers for disease activity.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 80
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - age = 18 years - diagnostic endoscopy was performed - diagnosis results available - 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 - gastrointestinal cancer - lack of informed consent

Study Design


Locations

Country Name City State
Germany Medical Center University of Freiburg Freiburg Baden-Württemberg

Sponsors (1)

Lead Sponsor Collaborator
University of Freiburg

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Kohler N, Zeiser R. Intestinal Microbiota Influence Immune Tolerance Post Allogeneic Hematopoietic Cell Transplantation and Intestinal GVHD. Front Immunol. 2019 Jan 17;9:3179. doi: 10.3389/fimmu.2018.03179. eCollection 2018. — View Citation

Wehkamp J, Fellermann K, Herrlinger KR, Baxmann S, Schmidt K, Schwind B, Duchrow M, Wohlschlager C, Feller AC, Stange EF. Human beta-defensin 2 but not beta-defensin 1 is expressed preferentially in colonic mucosa of inflammatory bowel disease. Eur J Gastroenterol Hepatol. 2002 Jul;14(7):745-52. doi: 10.1097/00042737-200207000-00006. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Defensin Expression (mRNA) Analysis of alpha-defensin and beta-defensin mRNA expression by realtime PCR (qRT-PCR) 3 years
Primary Defensin Expression (peptide) Analysis of alpha-defensin and beta-defensin levels by immunohistochemistry 3 years
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