Gut Microbiome and Metabolic Pathways Changes in Vitiligo

Last updated: January 7, 2019
Sponsor: Xijing Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vitiligo

Treatment

N/A

Clinical Study ID

NCT03797417
XJPF-LCY-V201812
  • Ages 3-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Vitiligo is a chronic depigmenting autoimmune-associated skin disease and a growing psychological health concern because of its low quality of life. Genetics, immunology and environment triggers contribute to the pathophysiology of vitiligo. Identify and decrease the risk factors of vitiligo is very crucial for vitiligo treatment and prevention. Emerging evidence has linked gut microbiome to human autoimmune diseases. Here the investigators will analyze 10,913 metagenomes in stool samples from 100 adult vitiligo patients and gut microbiome associated metabolites in patients serum.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subjects who volunteered and signed Informed Consent Form；

  2. Male or female subjects 3-65 years of age；

  3. Clinically confirmed the diagnosis of advanced vitiligo as per the diagnostic criteriafor vitiligo specified in Clinical Dermatology;

  4. Stable vital signs.

Exclusion

Exclusion Criteria:

  1. Patients who had taken systemic or local treatment with vitiligo in the last month;

  2. Patients who had taken systemic antibiotics，systemic hormones，cytokines,immunosuppressors in the previous three months;

  3. The combination of other autoimmune diseases，gastrointestinal diseases, hepaticdiseases, psychiatric and psycho-related diseases, or other skin diseases;

  4. The combination of Serious, life-threatening condition such as cardiac diseases, renaldiseases, endocrine system disease, cancer, or immunodeficiency diseases;

  5. Women of child-bearing potential who are pregnant, plan to become pregnant during thestudy or are lactating；

  6. Any other condition that the investigator deems unsuitable for entering the study.

Study Design

Total Participants: 200
Study Start date:
September 18, 2018
Estimated Completion Date:
December 31, 2020

Study Description

Vitiligo, an autoimmune disease of the skin, is a commonly acquired chronic depigmenting disorder characterized by loss of epidermal melanocytes and progressive depigmentation clinically, affecting from 0.5% to 1% of the world population and about 1% in China Vitiligo can be a psychologically crushing associated with low quality of life, especially in colored skinned individuals. The pathoetiology of vitiligo is multifactorial and has genetic, immunological, and environmental components. Several environment-associated mechanisms have been implicated to explain melanocyte disappearance, including ultraviolet (UV) radiation exposure, repeated mechanical or thermal stress, and exposure to chemicals (especially phenols or catechols), but epidemiologic data remain limited.

Broader gut dysbioses have been identified as potential causes or contributing factors to human autoimmune diseases; however, human studies have not yet identified microbial compositional or functional triggers that are predictive of skin autoimmunity or vitiligo. Metabolites from intestinal microbiota are key determinants of host-microbe mutualism and, consequently, the health or disease of the intestinal tract. However, whether such host-microbe crosstalk influences inflammation in peripheral tissues, such as the skin, is poorly understood.

The investigators will perform a metagenome association study and serum metabolomics profiling in a cohort of vitiligo Chinese individuals.

Connect with a study center

  • Xijing Hospital

    Xi'an, Shaanxi 710032
    China

    Active - Recruiting

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