Foot-skin Microbiome and Metabolomics of Pitted Keratolysis (Foot-skin M&M)

March 14, 2024 updated by: Charussri Leeyaphan, Mahidol University

The Study of Foot-skin Microbiome and Metabolomics of Thai Naval Cadets With Pitted Keratolysis

This study aimed to investigate the skin microbiome and metabolomics of patients with pitted keratolysis.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Pitted keratolysis is a skin infectious disease which can cause an unpleasant smell that can affect self-confidence and interpersonal relationships. The research problem was initiated through a community outreach program organized by the Department of Dermatology Siriraj Hospital, Thailand. From many years of experiences, our dermatologist teams observed that pitted keratolysis was a common disease among naval cadets who wore enclosed footwear for long hours, and it was more prevalent after a boot camp that spanned over months. This disease is chronic with no efficient standard treatment and limited information on the pathogenesis of the disease. Therefore, we propose to conduct a study on the pathogenesis of pitted keratolysis and malodorous feet through a longitudinal study of foot-skin microbiome and associated volatile metabolomic profiles of foot odor. With the unique population, with similar age range, daily activities, and diet, this study will allow to focus on the association of changes in microbiome in relation to pathogenesis of pitted keratolysis and malodorous feet, with fewer cofounding factors.

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.

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

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

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Department of Dermatology Siriraj Hospital
    • Bangkok
      • Bangkoknoi, Bangkok, Thailand, 10700
        • Department of Dermatology Siriraj Hospital

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

Yes

Description

Inclusion Criteria:

  • Naval rating cadets at Chumpol Naval Rating School, Thailand who volunteer to participate in this study. Informed consent will be obtained from all participants.
  • 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 medication or topical antibiotics for pitted keratolysis within 2 weeks before the enrollment.
  • Volunteers who have taken oral antibiotics within 2 weeks before enrollment.

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

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Normal feet
  • Swab their feet to analyze foot microbiome via 16s DNA sequencing
  • Collect their socks to analyze metabolomics via gas chromatography
Experimental: 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.
Drug: 4%Chlorhexidine
4%Chlorhexidine was given to participants with foot odor for 2 weeks
Experimental: 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.
Drug: 4%Chlorhexidine
4%Chlorhexidine was given to participants with foot odor for 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of skin microbiome
Time Frame: 2 months
Foot-skin microbial profiles of healthy Thai people and patients with pitted keratolysis
2 months
Composition of microbiota at skin
Time Frame: 2 months
Foot-skin microbial profiles of healthy Thai people and patients with pitted keratolysis
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of metabolite in foot odor
Time Frame: 2 months
Metabolite profiling of foot odor
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Sumanas Bunyaratavej, MD, Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 1, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

February 25, 2021

First Submitted That Met QC Criteria

March 2, 2021

First Posted (Actual)

March 4, 2021

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PK microbiome and metabolomic

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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