Analysis of Intestinal Defensin Expression in Acute GVHD

Ulcerative Colitis Clinical Trial

Official title:

Analysis of Intestinal Defensin Expression in Patients With Acute Graft-versus-Host Disease (GVHD)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04522843
• Other study ID #: GVHD_Def
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• GVHD,Acute
• Morbus Crohn
• Ulcerative Colitis

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