Microbiota in Skin and Mucosa of Patients With Inflammatory Skin Diseases

NCT04215458 | Unknown DMC

• 1 other identifier: REG-102-2019
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

The pathogeneses of many inflammatory diseases are not completely understood, yet, dysregulation of the human microbiota is increasingly being investigated as a possible contributing factor. The human microbiota includes bacteria, archaea, viruses and fungi. In general, little is known about the fungal colonization in inflammatory skin diseases. This study aims to examine the prevalence of microbiome in skin and oral mucosa of a variety of patients and healthy volunteers visiting the Dermatological outpatient clinic. The study is designed as a case-control study comparing the incidence of colonization or infection in skin and oral mucosa of patients with different skin diseases and healthy volunteers. Patients with selected skin diseases, staff at Zealand University Hospital in Roskilde, relatives to staff and students with relation to the Dermatologic Department will be asked to fill out a short questionnaire and have swaps taken from oral mucosa, as well as skin scrapings and tape strips from lesional skin (only patients) and non-lesional skin (all).

Conditions

Fungal Infection; Inflammatory Skin Disease; Yeast Infection Skin

Keywords

fungal colonization; inflammatory skin disease; yeast infection in skin

Outcome Measures

Primary Outcomes (1)

• prevalence of yeast colonization

  detection of possible yeasts on the skin

  at baseline

Secondary Outcomes (1)

• subtyping the possible yeasts found on the skin

  at baseline

Study Arms (1)

sample collection

OTHER

Collection of samples investigating for yeast colonization in either patients with inflammatory skin disease or healthy controls.

Other: sample collection (swap or tape strip)

Interventions

sample collection (swap or tape strip) OTHER

collection of swap or tape strip to determine yeast colonization in skin

sample collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Legally competent women and men
• Age 18 years or older

You may not qualify if:

• Actual systemic or topical antifungal therapy
• Pregnant or lactating women

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Zealand University Hospital Roskilde

Roskilde, 4000, Denmark

Location

MeSH Terms

Conditions

Mycoses; Dermatitis

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Central Study Contacts

Ditte M L Saunte, MD, PhD

CONTACT

+4547322600; disa@regionsjaelland.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The staff that analyses the samples will not know whether they come from patients or volounteers
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant, PhD

Model Details: case-control study

Study Record Dates

• First Submitted: December 28, 2019
• First Posted: January 2, 2020
• Study Start: September 1, 2021
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: July 20, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)