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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

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.

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Conditions studied

  • Vitiligo
  • Healthy

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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.

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

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
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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

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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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Registry details

Key details

Study ID
NCT03577327
Lead sponsor
Northwestern University
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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