Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Gut and Skin Microbiome in Vitiligo Disease Progression

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: 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

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Adults with vitiligo
Healthy adults


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location contacts
Contact: Dermatology CTU 312-503-5944 NUdermatologyCTU@northwestern.edu

Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: I. Caroline Le Poole Northwestern University
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
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

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