Foot-skin Microbiome and Metabolomics of Pitted Keratolysis
NCT ID: NCT04781036
Last Updated: 2024-03-18
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
250 participants
INTERVENTIONAL
2023-05-01
2024-12-01
Brief Summary
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Detailed Description
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The skin microbiome is a group of various microorganisms, such as bacteria, fungi, and viruses, residing on skin. Human skin microbiome can differ with respect to age, ethnicity, diet, climate and environment. Recently, there have been numerous studies highlighting the association of microbes with pathogenesis of various skin diseases, such as atopic dermatitis, acne vulgaris, and psoriasis (references?). In this project, we hypothesize that the alteration of skin microbiome as well as changes in metabolite profiles can be associated with the mechanism of the disease. The skin microbiome data generated in this study will be analyzed for microbial profiles using the QIIME2, a next-generation microbiome bioinformatics platform, and a graphic software package, "Statistical Analysis of Taxonomic and Functional Profiles" (STAMP). In parallel, we will apply a high throughput gas chromatography mass-spectrometry-based metabolomics to detect volatile metabolites present in foot odor in association with the observed foot-skin microbiome. This metabolite information will not only provide an additional aspect of pathogenesis of the disease but also might offer a new standard indicator of foot odor that can be further used in clinical practice. Finally, skin microbiome and metabolomic data will be analyzed using various methods of correlation analysis as well as integrative analysis to gain deeper understanding of the disease mechanism at the molecular levels.
The outcomes of this project will provide insights into the pathogenesis of pitted keratolysis. The scientific knowledge gained from the study will be translated into a more effective treatment of the disease. The human microbiome of healthy population and the disease-specific microbiome data will lay the groundwork to develop a human microbiome database for Thai people. Additionally, the success of the project will allow the development of advanced instrumental methodology and an integrative analysis approach to analyze multi -omics data, which will be great assets in advancing multidisciplinary research.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Normal feet
* Swab their feet to analyze foot microbiome via 16s DNA sequencing
* Collect their socks to analyze metabolomics via gas chromatography
No interventions assigned to this group
Foot odor without pitted keratolysis
* Swab their feet to analyze foot microbiome via 16s DNA sequencing
* Collect their socks to analyze metabolomics via gas chromatography
* Apply 4% chlorhexidine for 2 weeks
* Re-evaluate their feet at time of treatment finish and 1 months after treatment finish. The forementioned methods (swab and collect their socks) will be applied on their feet again.
* The microbiome and metabolomics will be analyzed to evaluate the difference of microbe and substances after treatment.
4%Chlorhexidine
4%Chlorhexidine was given to participants with foot odor for 2 weeks
Foot odor with pitted keratolysis
* Swab their feet to analyze foot microbiome via 16s DNA sequencing
* Collect their socks to analyze metabolomics via gas chromatography
* Apply 4% chlorhexidine for 2 weeks
* Re-evaluate their feet at time of treatment finish and 1 months after treatment finish. The forementioned methods (swab and collect their socks) will be applied on their feet again.
* The microbiome and metabolomics will be analyzed to evaluate the difference of microbe and substances after treatment.
4%Chlorhexidine
4%Chlorhexidine was given to participants with foot odor for 2 weeks
Interventions
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4%Chlorhexidine
4%Chlorhexidine was given to participants with foot odor for 2 weeks
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years.
* No underlying disease.
* Normal BMI (18.5-22.9 kg/m2).
* No previous history of pitted keratolysis.
* No previous history of dermatophytosis complex.
* Refrain from washing their feet for 12 hours prior to sampling.
Exclusion Criteria
* Volunteers who have taken oral antibiotics within 2 weeks before enrollment.
18 Years
MALE
Yes
Sponsors
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Mahidol University
OTHER
Responsible Party
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Charussri Leeyaphan
Associate Professor
Principal Investigators
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Sumanas Bunyaratavej, MD
Role: PRINCIPAL_INVESTIGATOR
Mahidol University
Locations
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Department of Dermatology Siriraj Hospital
Bangkoknoi, Bangkok, Thailand
Department of Dermatology Siriraj Hospital
Bangkok, , Thailand
Countries
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References
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Other Identifiers
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PK microbiome and metabolomic
Identifier Type: -
Identifier Source: org_study_id
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