ClinicalTrials.gg
RecruitingNCT03577327Updated Jun 9, 2026

The Gut and Skin Microbiome in Vitiligo Disease Progression

An observational study in Vitiligo and Healthy, sponsored by Northwestern University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-09.

Sponsored by Northwestern University · Observational

From the registry’s dates

  • Started May 2019; still recruiting 7 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 89 Years
Sex
All
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Study 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.

02

Conditions studied

  • Vitiligo
  • Healthy

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03

In context

Vitiligo

343 studies on the registry are indexed under Vitiligo; 96 are open to participants now.

This study's planned enrollment of 100 is below the median of 114 across 67 observational studies indexed under Vitiligo.

Browse Vitiligo studies →

Lead sponsor

Northwestern University is the lead sponsor of 1,423 studies on the registry; 198 are open to participants now.

Of its 105 completed or terminated interventional studies of FDA-regulated products, 78 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 for this study and the Dermatology Tissue Acquisition and Biorepository (STU00009443)

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Adults with vitiligo
  • Healthy adults
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What researchers measure

Primary outcomes

  1. Microbiome composition

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

    Time frame: 12 months

  2. Disease Progression

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

    Time frame: 12 months

Secondary outcomes

  1. Diet History Food Frequencies

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

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2019 (actual). Primary completion is estimated for Dec 2026, 91 months after the start.

Of 25 observational studies under Vitiligo, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10. This study's planned 91 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 2, 2018
First posted
Jul 5, 2018
StartActual
May 30, 2019
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2026
Last update
Jun 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03577327
Responsible party
I Caroline Le Poole (Professor, Northwestern University) — Principal investigator
First posted
Jul 5, 2018
Start date
May 30, 2019
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jun 9, 2026

Study contacts

Dermatology CTU
Contact
NUdermatologyCTU@northwestern.edu
312-503-5944
I. Caroline Le Poole
principal investigator · Northwestern University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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