The Gut and Skin Microbiome in Vitiligo Disease Progression

Recruiting

• Conditions: Vitiligo; Healthy

• Registration Number: NCT03577327
• Lead Sponsor: Northwestern University

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2018-04-02
• Study First Submitted QC: 2018-07-02
• Study First Posted: 2018-07-05
• Study Start: 2019-05-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-09
• Primary Completion: 2024-06
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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)

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Microbiome composition	12 months	Diversity analysis of microbiome samples in control subjects versus vitiligo subjects (measured by number of bacteria species/sample)
Disease Progression	12 months	Disease progression in control subjects versus vitiligo subjects (measured by VASI score (0-100)).

Secondary Outcome Measures

Name	Time	Method
Diet History Food Frequencies	12 months	Scoring from diet history food frequency questionnaires (measured by average daily food frequency scores).

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States