CClinicalTrials.gg
CompletedNCT04522843Updated Dec 18, 2024

Analysis of Intestinal Defensin Expression in Acute GVHD

An observational study in GVHD,Acute, Ulcerative Colitis and Morbus Crohn, sponsored by University of Freiburg. Completed at 1 site in Germany. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-12-18.

Sponsored by University of Freiburg · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
80
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • GVHD,Acute
  • Ulcerative Colitis
  • Morbus Crohn
03

In context

Colitis

1,073 studies on the registry are indexed under Colitis; 133 are open to participants now.

This study's enrollment of 80 is below the median of 105 across 248 observational studies indexed under Colitis.

Browse Colitis studies →

Lead sponsor

University of Freiburg is the lead sponsor of 27 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients who underwent diagnostic endoscopy

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

Exclusion Criteria:

  • age \< 18 years
  • gastrointestinal cancer
  • lack of informed consent
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
80 participants (actual)
Patient registry
No

Groups and cohorts

  • Uninflamed intestine

    Patients who underwent diagnostic endoscopy and received a diagnosis of no intestinal inflammation

  • Colitis

    Patients with active colitis

  • Acute GVHD

    Patients with acute gastrointestinal (GI) GVHD

06

What researchers measure

Primary outcomes

  1. Defensin Expression (mRNA)

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

    Time frame: 3 years

  2. Defensin Expression (peptide)

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

    Time frame: 3 years

07

Study locations

1 site
  • Medical Center University of Freiburg
    Freiburg, Baden-Württemberg 79106, Germany
08

References and documents

Publications

  • 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. PubMed 12169983 ↗
  • 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. PubMed 30705680 ↗
  • Ruckert T, Andrieux G, Boerries M, Hanke-Muller K, Woessner NM, Doetsch S, Schell C, Aumann K, Kolter J, Schmitt-Graeff A, Schiff M, Braun LM, Haring E, Kissel S, Siranosian BA, Bhatt AS, Nordkild P, Wehkamp J, Jensen BAH, Minguet S, Duyster J, Zeiser R, Kohler N. Human beta-defensin 2 ameliorates acute GVHD by limiting ileal neutrophil infiltration and restraining T cell receptor signaling. Sci Transl Med. 2022 Dec 21;14(676):eabp9675. doi: 10.1126/scitranslmed.abp9675. Epub 2022 Dec 21. PubMed 36542690 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04522843
Lead sponsor
University of Freiburg
Responsible party
Robert Zeiser (Director of the Division of Tumor Immunology, University of Freiburg) — Principal investigator
First posted
Aug 21, 2020
Start date
Sep 1, 2018
Primary completion
Oct 30, 2024
Completion
Oct 30, 2024
Last update
Dec 18, 2024

Study contacts

Robert Zeiser, Prof. Dr.
principal investigator · Medical Center University of Freiburg

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion