Gut Microbiome and Metabolic Pathways Changes in Vitiligo

NCT ID: NCT03797417

Last Updated: 2019-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-18

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Gut Microbiome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Disease

patients with vitiligo

No interventions assigned to this group

Healthy Control

healthy control

No interventions assigned to this group

Eligibility Criteria

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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 criteria for vitiligo specified in Clinical Dermatology;
4. Stable vital signs.

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, hepatic diseases, psychiatric and psycho-related diseases, or other skin diseases;
4. The combination of Serious, life-threatening condition such as cardiac diseases, renal diseases, endocrine system disease, cancer, or immunodeficiency diseases;
5. Women of child-bearing potential who are pregnant, plan to become pregnant during the study or are lactating;
6. Any other condition that the investigator deems unsuitable for entering the study.
Minimum Eligible Age

3 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Li Chunying-1

Vice Chief

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chunying Li

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Locations

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Xijing Hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qingrong Ni

Role: CONTACT

15109230226 ext. +86

Facility Contacts

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Xijing Hospital

Role: primary

Qingrong Ni

Role: backup

15109230226 ext. +86

Other Identifiers

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XJPF-LCY-V201812

Identifier Type: -

Identifier Source: org_study_id

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