The Skin Microbiome in Graft Versus Host Disease

NCT04231500 | Active Not Recruiting

• 1 other identifier: 2019-01939; sp19Mueller5
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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

Skin Microbiome; Graft Versus Host Disease; Graft Versus Host Disease in Skin

Keywords

allogeneic Hematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (6)

• Determination of the bacterial microbiome of patients with GVHD after allo-HSCT vs. patients without GVHD after allo-HSCT

  After lysis of the microbiota, the DNA is extracted for phylogenetic 16S ribosomal RNA gene sequencing (standard illumina protocol), which is considered the current gold standard to determine the bacterial microbiome

  at week 4 after transplantation

• Determination of the bacterial microbiome of patients with GVHD after allo-HSCT vs. patients without GVHD after allo-HSCT

  After lysis of the microbiota, the DNA is extracted for phylogenetic 16S ribosomal RNA gene sequencing (standard illumina protocol), which is considered the current gold standard to determine the bacterial microbiome

  at week 12 after transplantation

• Determination of the bacterial microbiome of patients with GVHD after allo-HSCT vs. patients without GVHD after allo-HSCT

  After lysis of the microbiota, the DNA is extracted for phylogenetic 16S ribosomal RNA gene sequencing (standard illumina protocol), which is considered the current gold standard to determine the bacterial microbiome

  at week 24 after transplantation

• Determination of the bacterial microbiome of patients with GVHD after allo-HSCT vs. patients without GVHD after allo-HSCT

  After lysis of the microbiota, the DNA is extracted for phylogenetic 16S ribosomal RNA gene sequencing (standard illumina protocol), which is considered the current gold standard to determine the bacterial microbiome

  at week 36 after transplantation

• Determination of the bacterial microbiome of patients with GVHD after allo-HSCT vs. patients without GVHD after allo-HSCT

  After lysis of the microbiota, the DNA is extracted for phylogenetic 16S ribosomal RNA gene sequencing (standard illumina protocol), which is considered the current gold standard to determine the bacterial microbiome

  at week 52 after transplantation

• Change in skin-microbiota in lesional vs. non-lesional skin of patients with GVHD

  After lysis of the microbiota, the DNA is extracted for phylogenetic 16S ribosomal RNA gene sequencing (standard illumina protocol), which is considered the current gold standard to determine the bacterial microbiome

  before transplantation and at week 4, week 12, week 24, week 36 and at week 52 after transplantation

Secondary Outcomes (8)

• Change in inter-individual skin-microbiota in allo-HSCT patients

  before transplantation and at week 4, week 12, week 24, week 36 and at week 52 after transplantation

• Change in intra-individual skin-microbiota in allo-HSCT patients

  before transplantation and at week 4, week 12, week 24, week 36 and at week 52 after transplantation

• Change of the skin-microbiota in correlation with the frequency and type of posttransplant infections (e.g. episodes of bacteraemia).

  before transplantation and at week 4, week 12, week 24, week 36 and at week 52 after transplantation

• Change of the composition of skin-microbiota in correlation with the severity of GVHD

  before transplantation and at week 4, week 12, week 24, week 36 and at week 52 after transplantation

• Change in Dermatology Life Quality Index (DLQI)

  before transplantation and at week 4, week 12, week 24, week 36 and at week 52 after transplantation

Study Arms (2)

patients with GVHD after allo-HSCT

Exploration of the skin-microbiota in patients with GVHD after allo-HSCT by sampling of skin swabs and a skin punch biopsy before conditioning procedure and additional skin biopsies from affected and healthy skin sites in case of GVHD

Diagnostic Test: Skin swabs; Diagnostic Test: Skin punch biopsies; Diagnostic Test: additional blood sampling

patients without GVHD after allo-HSCT

Exploration of the skin-microbiota in patients without GVHD after allo-HSCT by sampling of skin swabs and a skin punch biopsy before conditioning procedure

Diagnostic Test: Skin swabs; Diagnostic Test: Skin punch biopsies; Diagnostic Test: additional blood sampling

Interventions

Skin swabs DIAGNOSTIC_TEST

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.

patients with GVHD after allo-HSCT; patients without GVHD after allo-HSCT

Skin punch biopsies DIAGNOSTIC_TEST

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.

patients with GVHD after allo-HSCT; patients without GVHD after allo-HSCT

additional blood sampling DIAGNOSTIC_TEST

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.

patients with GVHD after allo-HSCT; patients without GVHD after allo-HSCT

Eligibility Criteria

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

Study Population

All patients undergoing allo-HSCT at the University Hospital Basel

You may qualify if:

• undergoing allo-HSCT at the University Hospital Basel

You may not qualify if:

• missing ability to judge
• illiteracy or lack of German, French or English language

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Gottfried und Julia Bangerter- Rhyner-Stiftung, Basel: collaborator

Study Sites (1)

Department of Dermatology; University Hospital Basel

Basel, 4031, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

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. Metagenomic sequencing of the punch biopsies will be performed. Biological material is appropriately stored for 20 years at the Division of Clinical Bacteriology/Mycology - in locked freezers in a restricted area only accessible to authorized personnel.

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Simon Mueller, PD Dr. med

  Department of Dermatology; University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: January 18, 2020
• Study Start: March 1, 2023
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: April 3, 2025

Record last verified: 2025-03

Locations

CH (1)