The Skin Microbiome in Graft Versus Host Disease

Active, not recruiting

• Conditions: Skin Microbiome; Graft Versus Host Disease; Graft Versus Host Disease in Skin
• Interventions: Diagnostic Test: Skin swabs; Diagnostic Test: Skin punch biopsies; Diagnostic Test: additional blood sampling

• Registration Number: NCT04231500
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-13
• Study First Submitted QC: 2020-01-13
• Study First Posted: 2020-01-18
• Study Start: 2023-03-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-03
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• undergoing allo-HSCT at the University Hospital Basel

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with GVHD after allo-HSCT	additional blood sampling	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
patients without GVHD after allo-HSCT	Skin punch biopsies	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
patients with GVHD after allo-HSCT	Skin punch biopsies	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
patients with GVHD after allo-HSCT	Skin swabs	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
patients without GVHD after allo-HSCT	Skin swabs	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
patients without GVHD after allo-HSCT	additional blood sampling	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

Primary Outcome Measures

Name	Time	Method
Determination of the bacterial microbiome of patients with GVHD after allo-HSCT vs. patients without GVHD after allo-HSCT	at week 52 after transplantation	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
Change in skin-microbiota in lesional vs. non-lesional skin of patients with GVHD	before transplantation and at week 4, week 12, week 24, week 36 and at week 52 after transplantation	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

Secondary Outcome Measures

Name	Time	Method
Change in Worst Itch Numerical Rating Scale (WINRS)	before transplantation and at week 4, week 12, week 24, week 36 and at week 52 after transplantation	Single-item numerical rating scale anchored at 0 and 10, on which 0 represents "no itching" and 10 represents "worst itch imaginable". The patient indicates the overall severity of itching attributable to his or her psoriatic skin condition by circling the number that best describes the worst level of itching in the past 24 hours.
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	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
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	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
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	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
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	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
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	There are 10 questions, covering the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, treatment. Each question refers to the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range form 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life).
Change in Eppendorf Itch Questionnaire (EIQ)	before transplantation and at week 4, week 12, week 24, week 36 and at week 52 after transplantation	The questionnaire consists of two pages, which are filled in by the patient. Form 1 presents 80 randomized descriptors. Sensory items are grouped on the left side and more affective or emotional items of different intensity values are found on the right side. Every item is scored within the range of 0 ('not true') to 4 ('describes exactly my itch sensation'). Statistically evaluable intensities can be derived from form 1 for every item. Form 2 deals with temporary and topographic aspects. Anti-itch ('pruritofensive') measures are grouped here and itch intensity is rated on a visual analog scale.
Change in Hospital Anxiety and Depression Scale (HADS)	before transplantation and at week 4, week 12, week 24, week 36 and at week 52 after transplantation	The HADS is a fourteen item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. Scores of greater than or equal to 11 on either scale indicate a definitive case.

Trial Locations

Locations (1)

Department of Dermatology; University Hospital Basel; 🇨🇭 Basel, Switzerland