Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04781036
Recruitment Status : Not yet recruiting
First Posted : March 4, 2021
Last Update Posted : March 4, 2021
Sponsor:
Information provided by (Responsible Party):
Charussri Leeyaphan, Mahidol University

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

Condition or disease Intervention/treatment Phase
Microbial Disease Metabolomics Drug: 4%Chlorhexidine Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Study of Foot-skin Microbiome and Metabolomics of Thai Naval Cadets With Pitted Keratolysis
Estimated Study Start Date : December 1, 2021
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : March 11, 2023


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 1 month
  • Re-evaluate their feet at time of treatment finish and 2 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 1 month.

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 1 month
  • Re-evaluate their feet at time of treatment finish and 2 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 1 month.




Primary Outcome Measures :
  1. Amount of skin microbiome [ Time Frame: 3 months ]
    Foot-skin microbial profiles of healthy Thai people and patients with pitted keratolysis

  2. Composition of microbiota at skin [ Time Frame: 3 months ]
    Foot-skin microbial profiles of healthy Thai people and patients with pitted keratolysis


Secondary Outcome Measures :
  1. Amount of metabolite in foot odor [ Time Frame: 3 months ]
    Metabolite profiling of foot odor



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04781036


Contacts
Layout table for location contacts
Contact: Charassri Leeyaphan, MD +66815959105 charussrilee@gmail.com
Contact: Sumanas Bunyaratavej, MD +6624194333 consultskin@yahoo.com

Locations
Layout table for location information
Thailand
Department of Dermatology Siriraj Hospital
Bangkoknoi, Bangkok, Thailand, 10700
Department of Dermatology Siriraj Hospital
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
Layout table for investigator information
Principal Investigator: Sumanas Bunyaratavej, MD Mahidol University
Publications of Results:

Other Publications:
Bolyen E, Rideout JR, Dillon MR, Bokulich NA, Abnet CC, Al-Ghalith GA, Alexander H, Alm EJ, Arumugam M, Asnicar F, Bai Y, Bisanz JE, Bittinger K, Brejnrod A, Brislawn CJ, Brown CT, Callahan BJ, Caraballo-Rodríguez AM, Chase J, Cope EK, Da Silva R, Diener C, Dorrestein PC, Douglas GM, Durall DM, Duvallet C, Edwardson CF, Ernst M, Estaki M, Fouquier J, Gauglitz JM, Gibbons SM, Gibson DL, Gonzalez A, Gorlick K, Guo J, Hillmann B, Holmes S, Holste H, Huttenhower C, Huttley GA, Janssen S, Jarmusch AK, Jiang L, Kaehler BD, Kang KB, Keefe CR, Keim P, Kelley ST, Knights D, Koester I, Kosciolek T, Kreps J, Langille MGI, Lee J, Ley R, Liu YX, Loftfield E, Lozupone C, Maher M, Marotz C, Martin BD, McDonald D, McIver LJ, Melnik AV, Metcalf JL, Morgan SC, Morton JT, Naimey AT, Navas-Molina JA, Nothias LF, Orchanian SB, Pearson T, Peoples SL, Petras D, Preuss ML, Pruesse E, Rasmussen LB, Rivers A, Robeson MS 2nd, Rosenthal P, Segata N, Shaffer M, Shiffer A, Sinha R, Song SJ, Spear JR, Swafford AD, Thompson LR, Torres PJ, Trinh P, Tripathi A, Turnbaugh PJ, Ul-Hasan S, van der Hooft JJJ, Vargas F, Vázquez-Baeza Y, Vogtmann E, von Hippel M, Walters W, Wan Y, Wang M, Warren J, Weber KC, Williamson CHD, Willis AD, Xu ZZ, Zaneveld JR, Zhang Y, Zhu Q, Knight R, Caporaso JG. Author Correction: Reproducible, interactive, scalable and extensible microbiome data science using QIIME 2. Nat Biotechnol. 2019 Sep;37(9):1091. doi: 10.1038/s41587-019-0252-6.

Layout table for additonal information
Responsible Party: Charussri Leeyaphan, Associate Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT04781036    
Other Study ID Numbers: PK microbiome and metabolomic
First Posted: March 4, 2021    Key Record Dates
Last Update Posted: March 4, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Charussri Leeyaphan, Mahidol University:
Pitted keratolysis
Microbiome
Metabolomics
Additional relevant MeSH terms:
Layout table for MeSH terms
Chlorhexidine
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants