- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03797417
Gut Microbiome and Metabolic Pathways Changes in Vitiligo
The Gut Microbiome and Metabolic Activity in Patients With Vitiligo
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Qingrong Ni
- Phone Number: +86 15109230226
- Email: nitina.tn@gmail.com
Study Locations
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Shaanxi
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Xi'an, Shaanxi, China, 710032
- Recruiting
- Xijing Hospital
-
Contact:
- Qingrong Ni
- Phone Number: +86 15109230226
- Email: nitina.tn@gmail.com
-
Contact:
- Xijing Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Subjects who volunteered and signed Informed Consent Form;
- Male or female subjects 3-65 years of age;
- Clinically confirmed the diagnosis of advanced vitiligo as per the diagnostic criteria for vitiligo specified in Clinical Dermatology;
- Stable vital signs.
Exclusion Criteria:
- Patients who had taken systemic or local treatment with vitiligo in the last month;
- Patients who had taken systemic antibiotics,systemic hormones,cytokines, immunosuppressors in the previous three months;
- The combination of other autoimmune diseases,gastrointestinal diseases, hepatic diseases, psychiatric and psycho-related diseases, or other skin diseases;
- The combination of Serious, life-threatening condition such as cardiac diseases, renal diseases, endocrine system disease, cancer, or immunodeficiency diseases;
- Women of child-bearing potential who are pregnant, plan to become pregnant during the study or are lactating;
- Any other condition that the investigator deems unsuitable for entering the study.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Disease
patients with vitiligo
|
Healthy Control
healthy control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gut microbiota sequencing results by analyzing metagenomes of 16s rRNA gene or microbial genes
Time Frame: 2018.10.1--2019.3.1
|
Fecal samples are obtained from all recruited subjects for metagenomic sequencing.
The individuals have not received any antibiotic treatment for at least one month before sample collection.
In the seven days before sample collection, subjects did not take any food containing probiotics such as yogurt.
Each sample was either frozen immediately at -80 °C or briefly stored in personal -20 °C freezers before transport to the laboratory within 24 h.
After extracting DNA from fecal samoles, gut microbiota sequencing results by using Shotgun Strategy or Meta 16s high-throughput sequencing.
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2018.10.1--2019.3.1
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Gut microbiota associated metabolic pathways by using metabolomics profiling of serum samples study
Time Frame: 2018.12.1--2019.3.1
|
All serum samples will be thawed on ice and a quality control (QC) sample, made by mixing and blending equal volumes (10 μl) of each serum sample, is used to estimate a mean profile representing all the analytes encountered during analysis.
The acquired MS data pretreatments included peak selection and grouping, retention time correction, second peak grouping, and isotopes and adducts annotation, will be performed as previously described56.
LC-MS raw data files will be converted into mzXML format and then analyzed by the XCMS and CAMERA toolbox with R statistical language.
|
2018.12.1--2019.3.1
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Vitiligo associated activity measurements like VASI assays, serum markers detection
Time Frame: 2019.1--2019.3.1
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VASI assays will be used to evaluate patients disease condition.
VASI Scoring Criteria VASI=Σall body sites (hand units) × depigmentation.
Serum markers like CXCL10, IL-2, and sCD25 will be detected by ELISA kits.
|
2019.1--2019.3.1
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chunying Li, Study Principal Investigator
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- XJPF-LCY-V201812
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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