The Gut and Skin Microbiome in Vitiligo Disease Progression

Healthy Clinical Trial

Official title:

The Gut and Skin Microbiome in Vitiligo Disease Progression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03577327
• Other study ID #: ICLP10302017
• Status: Recruiting
• Start date: May 30, 2019
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: Northwestern University
• Contact: Dermatology CTU
• Phone: 312-503-5944
• Email: NUdermatologyCTU[@]northwestern.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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. The investigators aim to answer the question whether the gut and skin microbiome of patients with vitiligo differs from the general population.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease Progression
• Healthy
• Vitiligo

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbiome composition	Diversity analysis of microbiome samples in control subjects versus vitiligo subjects (measured by number of bacteria species/sample)	12 months
Primary	Disease Progression	Disease progression in control subjects versus vitiligo subjects (measured by VASI score (0-100)).	12 months
Secondary	Diet History Food Frequencies	Scoring from diet history food frequency questionnaires (measured by average daily food frequency scores).	12 months