The Skin Microbiome in Graft Versus Host Disease

Graft Versus Host Disease Clinical Trial

Official title:

The Skin Microbiome in Graft Versus Host Disease Dynamics of the Skin-microbiota After Allogeneic Stem Cell Transplantation - a Predictive Marker for Graft Versus Host Disease?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04231500
• Other study ID #: 2019-01939; sp19Mueller5
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: March 2027

Study information

• Verified date: February 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Simon Mueller, PD Dr. med
• Phone: +41 61 328 69 64
• Email: simon.mueller[@]usb.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2027
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Graft Versus Host Disease
• Graft Versus Host Disease in Skin
• Graft vs Host Disease
• Skin Microbiome

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Switzerland	Department of Dermatology; University Hospital Basel	Basel

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Gottfried und Julia Bangerter- Rhyner-Stiftung, Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Change in inter-individual skin-microbiota in allo-HSCT patients	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	Change in intra-individual skin-microbiota in allo-HSCT patients	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	Change of the skin-microbiota in correlation with the frequency and type of posttransplant infections (e.g. episodes of bacteraemia).	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	Change of the composition of skin-microbiota in correlation with the severity of 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	Change in Dermatology Life Quality Index (DLQI)	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).	before transplantation and at week 4, week 12, week 24, week 36 and at week 52 after transplantation
Secondary	Change in Worst Itch Numerical Rating Scale (WINRS)	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.	before transplantation and at week 4, week 12, week 24, week 36 and at week 52 after transplantation
Secondary	Change in Eppendorf Itch Questionnaire (EIQ)	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.	before transplantation and at week 4, week 12, week 24, week 36 and at week 52 after transplantation
Secondary	Change in Hospital Anxiety and Depression Scale (HADS)	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.	before transplantation and at week 4, week 12, week 24, week 36 and at week 52 after transplantation