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The Gut and Skin Microbiome in Vitiligo Disease Progression

Sponsor
Northwestern University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03577327
Collaborator
(none)
100
Enrollment
1
Location
54.1
Anticipated Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Investigators plan to perform a pilot study that aims to characterize the microbiome of human vitiligo patients with both active and stable disease and compare this to the microbiome of age and sex matched controls. The investigators aim to answer the question whether the gut and skin microbiome of patients with vitiligo differs from the general population.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Gut and Skin Microbiome in Vitiligo Disease Progression
    Actual Study Start Date :
    May 30, 2019
    Anticipated Primary Completion Date :
    Jun 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Adults with vitiligo
    Healthy adults

    Outcome Measures

    Primary Outcome Measures

    1. Microbiome composition [12 months]

      Diversity analysis of microbiome samples in control subjects versus vitiligo subjects (measured by number of bacteria species/sample)

    2. Disease Progression [12 months]

      Disease progression in control subjects versus vitiligo subjects (measured by VASI score (0-100)).

    Secondary Outcome Measures

    1. Diet History Food Frequencies [12 months]

      Scoring from diet history food frequency questionnaires (measured by average daily food frequency scores).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 89 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Patients with and/or without vitiligo lesional expansion over the past year.

    • Age/sex-matched controls who do not have a diagnosis of vitiligo

    • Subjects who are age 18-89 years of age at time of enrollment

    • Subjects who are able and willing to give informed consent for this study and the Dermatology Tissue Acquisition and Biorepository (STU00009443)

    Exclusion Criteria:

    • Subjects who are younger than 18 years of age or 90 years of age or older

    • Subjects who are unable to give consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Northwestern University Chicago Illinois United States 60611

    Sponsors and Collaborators

    • Northwestern University

    Investigators

    • Principal Investigator: I. Caroline Le Poole, Northwestern University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    I Caroline Le Poole, Professor, Northwestern University
    ClinicalTrials.gov Identifier:
    NCT03577327
    Other Study ID Numbers:
    • ICLP10302017
    First Posted:
    Jul 5, 2018
    Last Update Posted:
    Apr 6, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Vitiligo
    Disease Progression

    Study Results

    No Results Posted as of Apr 6, 2022