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The Gut and Skin Microbiome in Vitiligo Disease Progression

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ClinicalTrials.gov Identifier: NCT03577327
Recruitment Status : Recruiting
First Posted : July 5, 2018
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
I Caroline Le Poole, Northwestern University

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
Vitiligo Healthy

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Study Type : Observational
Estimated 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
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Vitiligo
MedlinePlus related topics: Vitiligo

Group/Cohort
Adults with vitiligo
Healthy adults



Primary Outcome Measures :
  1. Microbiome composition [ Time Frame: 12 months ]
    Diversity analysis of microbiome samples in control subjects versus vitiligo subjects (measured by number of bacteria species/sample)

  2. Disease Progression [ Time Frame: 12 months ]
    Disease progression in control subjects versus vitiligo subjects (measured by VASI score (0-100)).


Secondary Outcome Measures :
  1. Diet History Food Frequencies [ Time Frame: 12 months ]
    Scoring from diet history food frequency questionnaires (measured by average daily food frequency scores).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adults with or without vitiligo who are under the age of 90 years old.
Criteria

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

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): NCT03577327


Contacts
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Contact: Dermatology CTU 312-503-5944 NUdermatologyCTU@northwestern.edu

Locations
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United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Dermatology CTU    312-503-5944    NUdermatologyCTU@northwestern.edu   
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: I. Caroline Le Poole Northwestern University
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Responsible Party: I Caroline Le Poole, Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT03577327    
Other Study ID Numbers: ICLP10302017
First Posted: July 5, 2018    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vitiligo
Disease Progression
Disease Attributes
Pathologic Processes
Hypopigmentation
Pigmentation Disorders
Skin Diseases