Clinical trial NCT03797417: Gut Microbiome and Metabolic Pathways Changes in Vitiligo
Official title: The Gut Microbiome and Metabolic Activity in Patients With Vitiligo
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gut Microbiome
Keywords: Gut Microbiome
Vitiligo
Metabolic Pathways
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2019-01-09
Enrollment: 200
Sex: ALL
Minimum age (years): 3
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We recruit patients who have clinically advanced vitiligo, and barely have other diseases which may disturb our study results.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Gut microbiota sequencing results by analyzing metagenomes of 16s rRNA gene or microbial genes
timeFrame: 2018.10.1--2019.3.1
measure: Gut microbiota associated metabolic pathways by using metabolomics profiling of serum samples study
timeFrame: 2018.12.1--2019.3.1
measure: Vitiligo associated activity measurements like VASI assays, serum markers detection
timeFrame: 2019.1--2019.3.1
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Study Principal Investigator
name: Chunying Li
role: PRINCIPAL_INVESTIGATOR
References: