Clinical trial NCT04231500: The Skin Microbiome in Graft Versus Host Disease
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?
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Skin Microbiome
Graft Versus Host Disease
Graft Versus Host Disease in Skin
Keywords: allogeneic Hematopoietic Stem Cell Transplantation
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Gottfried und Julia Bangerter- Rhyner-Stiftung, Basel
First posted: 2020-01-18
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients undergoing allo-HSCT at the University Hospital Basel

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.


Eligibility criteria: 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

Primary outcomes:
measure: Determination of the bacterial microbiome of patients with GVHD after allo-HSCT vs. patients without GVHD after allo-HSCT
timeFrame: at week 4 after transplantation
measure: Determination of the bacterial microbiome of patients with GVHD after allo-HSCT vs. patients without GVHD after allo-HSCT
timeFrame: at week 12 after transplantation
measure: Determination of the bacterial microbiome of patients with GVHD after allo-HSCT vs. patients without GVHD after allo-HSCT
timeFrame: at week 24 after transplantation
measure: Determination of the bacterial microbiome of patients with GVHD after allo-HSCT vs. patients without GVHD after allo-HSCT
timeFrame: at week 36 after transplantation
measure: Determination of the bacterial microbiome of patients with GVHD after allo-HSCT vs. patients without GVHD after allo-HSCT
timeFrame: at week 52 after transplantation
measure: Change in skin-microbiota in lesional vs. non-lesional skin of patients with GVHD
timeFrame: before transplantation and at week 4, week 12, week 24, week 36 and at week 52 after transplantation
Secondary outcomes:
measure: Change in inter-individual skin-microbiota in allo-HSCT patients
timeFrame: before transplantation and at week 4, week 12, week 24, week 36 and at week 52 after transplantation
measure: Change in intra-individual skin-microbiota in allo-HSCT patients
timeFrame: before transplantation and at week 4, week 12, week 24, week 36 and at week 52 after transplantation
measure: Change of the skin-microbiota in correlation with the frequency and type of posttransplant infections (e.g. episodes of bacteraemia).
timeFrame: before transplantation and at week 4, week 12, week 24, week 36 and at week 52 after transplantation
measure: Change of the composition of skin-microbiota in correlation with the severity of GVHD
timeFrame: before transplantation and at week 4, week 12, week 24, week 36 and at week 52 after transplantation
measure: Change in Dermatology Life Quality Index (DLQI)
timeFrame: before transplantation and at week 4, week 12, week 24, week 36 and at week 52 after transplantation
measure: Change in Worst Itch Numerical Rating Scale (WINRS)
timeFrame: before transplantation and at week 4, week 12, week 24, week 36 and at week 52 after transplantation
measure: Change in Eppendorf Itch Questionnaire (EIQ)
timeFrame: before transplantation and at week 4, week 12, week 24, week 36 and at week 52 after transplantation
measure: Change in Hospital Anxiety and Depression Scale (HADS)
timeFrame: before transplantation and at week 4, week 12, week 24, week 36 and at week 52 after transplantation
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Dermatology; University Hospital Basel
Study officials:
affiliation: Department of Dermatology; University Hospital Basel
name: Simon Mueller, PD Dr. med
role: PRINCIPAL_INVESTIGATOR
References: