- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04231500
The Skin Microbiome in Graft Versus Host Disease
February 13, 2024 updated by: University Hospital, Basel, Switzerland
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?
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Simon Mueller, PD Dr. med
- Phone Number: +41 61 328 69 64
- Email: simon.mueller@usb.ch
Study Locations
-
-
-
Basel, Switzerland, 4031
- Recruiting
- Department of Dermatology; University Hospital Basel
-
Contact:
- Simon Mueller, PD Dr. med
- Phone Number: +41 61 328 69 64
- Email: simon.mueller@usb.ch
-
Sub-Investigator:
- Alexander Navarini, Prof. Dr. med
-
Sub-Investigator:
- Joerg Halter, PD Dr. med
-
Sub-Investigator:
- Jakob Passweg, Prof. Dr. med
-
Sub-Investigator:
- Helena Seth-Smith, Dr. phil.
-
Sub-Investigator:
- Adrian Egli, PD Dr. med. Dr. phil.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
All patients undergoing allo-HSCT at the University Hospital Basel
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
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.
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.
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 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
|
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.
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
at week 4 after transplantation
|
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
|
at week 12 after transplantation
|
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
|
at week 24 after transplantation
|
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
|
at week 36 after transplantation
|
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
|
at week 52 after transplantation
|
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
|
before transplantation and at week 4, week 12, week 24, week 36 and at week 52 after transplantation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
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
|
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).
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
|
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
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
|
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)
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).
|
before transplantation and at week 4, week 12, week 24, week 36 and at week 52 after transplantation
|
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.
|
before transplantation and at week 4, week 12, week 24, week 36 and at week 52 after transplantation
|
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.
|
before transplantation and at week 4, week 12, week 24, week 36 and at week 52 after transplantation
|
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.
|
before transplantation and at week 4, week 12, week 24, week 36 and at week 52 after transplantation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Simon Mueller, PD Dr. med, Department of Dermatology; University Hospital Basel
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2023
Primary Completion (Estimated)
March 1, 2026
Study Completion (Estimated)
March 1, 2027
Study Registration Dates
First Submitted
January 13, 2020
First Submitted That Met QC Criteria
January 13, 2020
First Posted (Actual)
January 18, 2020
Study Record Updates
Last Update Posted (Estimated)
February 14, 2024
Last Update Submitted That Met QC Criteria
February 13, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-01939; sp19Mueller5
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Graft Versus Host Disease
-
University of LiegeTerminatedChronic Graft-Versus-Host Disease | Acute Graft-Versus-Host Disease | Steroid Refractory Graft-Versus-Host DiseaseBelgium
-
Jazz PharmaceuticalsCompletedAcute-graft-versus-host Disease | Graft-versus-host DiseaseUnited States, Belgium, United Kingdom, Greece, Germany, Spain, France, Italy, Austria, Canada, Bulgaria, Croatia, Poland, Portugal
-
Mesoblast, Inc.Quintiles, Inc.CompletedGrade B Acute Graft Versus Host Disease | Grade C Acute Graft Versus Host Disease | Grade D Acute Graft Versus Host DiseaseUnited States
-
Grupo Espanol de trasplantes hematopoyeticos y...CompletedChronic Graft-Versus-Host DiseaseSpain
-
National Cancer Institute (NCI)TerminatedGraft vs Host Disease | Graft-Versus-Host Disease | Chronic Graft vs. Host DiseaseUnited States
-
H. Lee Moffitt Cancer Center and Research InstituteNovartisCompletedGraft-Versus-Host DiseaseUnited States
-
M.D. Anderson Cancer CenterCompleted
-
John LevineCompletedGVHD | Low Risk Acute Graft-versus-host Disease | Graft-versus-host-diseaseUnited States
-
AltruBio Inc.CompletedSteroid-refractory Acute Graft-versus-Host Disease | Treatment-refractory Acute Graft-versus-Host DiseaseUnited States
-
Jonsson Comprehensive Cancer CenterWithdrawnAcute Graft Versus Host Disease | Gastrointestinal Tract Acute Graft Versus Host Disease | Severe Gastrointestinal Tract Acute Graft Versus Host Disease | Steroid Resistant Gastrointestinal Tract Acute Graft Versus Host DiseaseUnited States
Clinical Trials on Skin swabs
-
University Hospital, BordeauxCentre National de la Recherche Scientifique, FranceNot yet recruitingVitiligo | Skin MelanomaFrance
-
CHU de ReimsUnknownBullous PemphigoidFrance
-
University of California, IrvinePfizerCompletedAtopic Dermatitis | Atopic Dermatitis EczemaUnited States
-
University Hospital Inselspital, BerneActive, not recruiting
-
Larimar Therapeutics, Inc.Clinilabs, Inc.CompletedHealthy Volunteers | Friedreich AtaxiaUnited States
-
Assistance Publique Hopitaux De MarseilleCompletedEndemic and Emerging Diseases in Populations of HomelessFrance
-
Western Galilee Hospital-NahariyaRecruiting
-
Systagenix Wound ManagementCompletedChronic Wounds With Different EtiologiesUnited States
-
Meir Medical CenterCompleted
-
Systagenix Wound ManagementCompleted