Gut Microbiome and Metabolic Pathways Changes in Vitiligo

NCT03797417 | Unknown

• 1 other identifier: XJPF-LCY-V201812
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Gut Microbiome

Keywords

Gut Microbiome; Vitiligo; Metabolic Pathways

Outcome Measures

Primary Outcomes (3)

• Gut microbiota sequencing results by analyzing metagenomes of 16s rRNA gene or microbial genes

  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.

  2018.10.1--2019.3.1

• Gut microbiota associated metabolic pathways by using metabolomics profiling of serum samples study

  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

• Vitiligo associated activity measurements like VASI assays, serum markers detection

  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

Study Arms (2)

Disease

patients with vitiligo

Healthy Control

healthy control

Eligibility Criteria

• Age: 3 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

the fecal and blood sample of recruited patients and healthy control volunteers

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Chunying Li

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qingrong Ni

CONTACT

15109230226; nitina.tn@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chief

Study Record Dates

• First Submitted: January 5, 2019
• First Posted: January 9, 2019
• Study Start: September 18, 2018
• Primary Completion: June 1, 2019
• Study Completion: December 31, 2020
• Last Updated: January 9, 2019

Record last verified: 2019-01

Locations

CN (1)