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The Skin Microbiome in Graft Versus Host Disease

NCT04231500 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 74

Last updated 2025-04-03

No results posted yet for this study

Summary

Based on the evidence on the impact of the intestinal microbiome on the Graft Versus Host Disease (GVHD) after allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT), it is hypothesized that the skin-microbiome may play a role in cutaneous GVHD as well. Therefore, this study aims at investigating the skin-microbiota of patients with GVHD after allo-HSCT and of patients without GVHD after allo-HSCT.

Conditions

Interventions

DIAGNOSTIC_TEST

Skin swabs

Pre-moistened skin swabs will be collected before the patient starts the conditioning regimens (before conditioning; start of HSCT = day 0, on the day of the transplantation an the repeated in week 4, 12, 24, 36 and 52 after allo-HSCT. The first swab serves as baseline reference (ideally taken at the earliest one week after a systemic antibiotic treatment). Swabs will be taken from the neck, back, right hip, buccal oral cavity and the genital mucosae. In patients who develop acute or chronic skin-GVHD additional swabs will be taken from affected skin at the time of diagnosis and then again according to the schedule of the non-lesioned skin swabs.

DIAGNOSTIC_TEST

Skin punch biopsies

During the first visit, a single skin punch biopsy will be taken to state the skin condition and microbiome before allo-HSCT. Further biopsies will only be taken in case of acute or chronic cutaneous GVHD. A 4-6 mm punch biopsy will be taken from the affected skin area and a second one from a nearby unaffected part of the skin. Before the biopsy, skin disinfection will be performed to avoid contamination with surface bacteria.

DIAGNOSTIC_TEST

additional blood sampling

an additional tube of blood (2.7ml) and an additional tube of serum (6ml) will be taken and frozen during visits 1, 2, 3 and 7 in the course of blood collection, in order to be able to carry out any later laboratory tests that may prove to be useful depending on the course of the study.

Sponsors & Collaborators

  • Gottfried und Julia Bangerter- Rhyner-Stiftung, Basel

    collaborator OTHER

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Simon Mueller, PD Dr. med · Department of Dermatology; University Hospital Basel

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04231500 on ClinicalTrials.gov