The Gut and Skin Microbiome in Vitiligo Disease Progression
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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
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Condition or disease |
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Vitiligo Healthy |
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 |

Group/Cohort |
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Adults with vitiligo |
Healthy adults |
- Microbiome composition [ Time Frame: 12 months ]Diversity analysis of microbiome samples in control subjects versus vitiligo subjects (measured by number of bacteria species/sample)
- Disease Progression [ Time Frame: 12 months ]Disease progression in control subjects versus vitiligo subjects (measured by VASI score (0-100)).
- Diet History Food Frequencies [ Time Frame: 12 months ]Scoring from diet history food frequency questionnaires (measured by average daily food frequency scores).

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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 |
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

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
Contact: Dermatology CTU | 312-503-5944 | NUdermatologyCTU@northwestern.edu |
United States, Illinois | |
Northwestern University | Recruiting |
Chicago, Illinois, United States, 60611 | |
Contact: Dermatology CTU 312-503-5944 NUdermatologyCTU@northwestern.edu |
Principal Investigator: | I. Caroline Le Poole | Northwestern University |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Vitiligo Disease Progression Disease Attributes Pathologic Processes |
Hypopigmentation Pigmentation Disorders Skin Diseases |