Analysis of Intestinal Defensin Expression in Acute GVHD

NCT04522843 | Completed

• 1 other identifier: GVHD_Def
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

GVHD,Acute; Ulcerative Colitis; Morbus Crohn

Outcome Measures

Primary Outcomes (2)

• Defensin Expression (mRNA)

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

  3 years

• Defensin Expression (peptide)

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

  3 years

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients who underwent diagnostic endoscopy

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Freiburg: lead

Study Sites (1)

Medical Center University of Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Related Publications (3)

• 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.

  PMID: 12169983 BACKGROUND

• 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.

  PMID: 30705680 BACKGROUND

• 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.

  PMID: 36542690 RESULT

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Robert Zeiser, Prof. Dr.

  Medical Center University of Freiburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Division of Tumor Immunology

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 21, 2020
• Study Start: September 1, 2018
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)