The Gut and Skin Microbiome in Vitiligo Disease Progression

NCT03577327 | Recruiting

• 1 other identifier: ICLP10302017
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitiligo; Healthy

Outcome Measures

Primary Outcomes (2)

• Microbiome composition

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

  12 months

• Disease Progression

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

  12 months

Secondary Outcomes (1)

• Diet History Food Frequencies

  12 months

Study Arms (2)

Adults with vitiligo

Healthy adults

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with or without vitiligo who are under the age of 90 years old.

You may qualify if:

• 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)

You may not qualify if:

• Subjects who are younger than 18 years of age or 90 years of age or older
• Subjects who are unable to give consent

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• I. Caroline Le Poole

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dermatology CTU

CONTACT

312-503-5944; NUdermatologyCTU@northwestern.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 2, 2018
• First Posted: July 5, 2018
• Study Start: May 30, 2019
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)