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Active, Not Recruiting

NCT Number: NCT04231500

The Skin Microbiome in Graft Versus Host Disease

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Skin Microbiome Graft Versus Host Disease Graft Versus Host Disease in Skin Graft vs Host Disease Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Dermatology; University Hospital Basel

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

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

    Time frame: at week 4 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

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

    Time frame: at week 12 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

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

    Time frame: at week 24 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

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

    Time frame: at week 36 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

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

    Time frame: 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

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

    Time frame: 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 outcomes

  1. Change in inter-individual skin-microbiota in allo-HSCT patients

    Time frame: 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

  2. Change in intra-individual skin-microbiota in allo-HSCT patients

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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

  5. Change in Dermatology Life Quality Index (DLQI)

    Time frame: 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).

  6. Change in Worst Itch Numerical Rating Scale (WINRS)

    Time frame: 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.

  7. Change in Eppendorf Itch Questionnaire (EIQ)

    Time frame: 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.

  8. Change in Hospital Anxiety and Depression Scale (HADS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Gottfried und Julia Bangerter- Rhyner-Stiftung, Basel

Registry information

Official study 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?

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 18, 2020
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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