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NCT Number: NCT04522843

Analysis of Intestinal Defensin Expression in Acute GVHD

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.

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Key information

Conditions

GVHD,Acute Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Morbus Crohn Ulcerative Colitis

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical Center University of Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Defensin Expression (mRNA)

    Time frame: 3 years

    Analysis of alpha-defensin and beta-defensin mRNA expression by realtime PCR (qRT-PCR)

  2. Defensin Expression (peptide)

    Time frame: 3 years

    Analysis of alpha-defensin and beta-defensin levels by immunohistochemistry

Sponsors and collaborators

Lead sponsor

University of Freiburg

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Aug 21, 2020
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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