VitiligoNCT03577327
The Gut and Skin Microbiome in Vitiligo Disease Progression
An observational study of Vitiligo and Healthy, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2019to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults with or without vitiligo who are under the age of 90 years old.
Who may be able to join
- 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)
Who cannot join
- Subjects who are younger than 18 years of age or 90 years of age or older
- Subjects who are unable to give consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Dermatology CTU, 312-503-5944, NUdermatologyCTU@northwestern.edu
About this study
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.
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults with vitiligo | Not described | |
| Healthy adults | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome composition
Diversity analysis of microbiome samples in control subjects versus vitiligo subjects (measured by number of bacteria species/sample)
Measured: 12 months
Disease Progression
Disease progression in control subjects versus vitiligo subjects (measured by VASI score (0-100)).
Measured: 12 months
Secondary outcomes (1)
Diet History Food Frequencies
Scoring from diet history food frequency questionnaires (measured by average daily food frequency scores).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start30 May 2019
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, I Caroline Le Poole, Northwestern University
- Investigators
- I. Caroline Le Poole, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577327
- Sponsor's protocol ID
- ICLP10302017
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2018
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Gut and Skin Microbiome in Vitiligo Disease Progression
- ClinicalTrials.gov ID
- NCT03577327
- Acronym / sponsor ID
- ICLP10302017
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 30 May 2019 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adults with vitiligo | – | – |
| Healthy adults | – | – |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with or without vitiligo who are under the age of 90 years old.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- Subjects who are younger than 18 years of age or 90 years of age or older
- Subjects who are unable to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)).
1 secondary outcome
Diet History Food Frequencies
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
I. Caroline Le Poole principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitiligo and Healthy, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dermatology CTU (312-503-5944, NUdermatologyCTU@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiome composition (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.