The Gut and Skin Microbiome in Vitiligo Disease Progression

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 Overview

• Status: Recruiting
• Conditions: Healthy; Vitiligo

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Dermatology CTU; Phone Number: 312-503-5944; Email: NUdermatologyCTU@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University
      • Contact: Dermatology CTU; Phone Number: 312-503-5944; Email: NUdermatologyCTU@northwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Adults with vitiligo
Healthy adults

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diet History Food Frequencies	Scoring from diet history food frequency questionnaires (measured by average daily food frequency scores).	12 months

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: I. Caroline Le Poole, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2019
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: April 2, 2018
• First Submitted That Met QC Criteria: July 2, 2018
• First Posted (Actual): July 5, 2018

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Disease Attributes; Pigmentation Disorders; Hypopigmentation; Disease Progression; Vitiligo
• Other Study ID Numbers: ICLP10302017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No