<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03797417</url>
  </required_header>
  <id_info>
    <org_study_id>XJPF-LCY-V201812</org_study_id>
    <nct_id>NCT03797417</nct_id>
  </id_info>
  <brief_title>Gut Microbiome and Metabolic Pathways Changes in Vitiligo</brief_title>
  <official_title>The Gut Microbiome and Metabolic Activity in Patients With Vitiligo</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xijing Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xijing Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Vitiligo is a chronic depigmenting autoimmune-associated skin disease and a growing&#xD;
      psychological health concern because of its low quality of life. Genetics, immunology and&#xD;
      environment triggers contribute to the pathophysiology of vitiligo. Identify and decrease the&#xD;
      risk factors of vitiligo is very crucial for vitiligo treatment and prevention. Emerging&#xD;
      evidence has linked gut microbiome to human autoimmune diseases. Here the investigators will&#xD;
      analyze 10,913 metagenomes in stool samples from 100 adult vitiligo patients and gut&#xD;
      microbiome associated metabolites in patients serum.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Vitiligo, an autoimmune disease of the skin, is a commonly acquired chronic depigmenting&#xD;
      disorder characterized by loss of epidermal melanocytes and progressive depigmentation&#xD;
      clinically, affecting from 0.5% to 1% of the world population and about 1% in China Vitiligo&#xD;
      can be a psychologically crushing associated with low quality of life, especially in colored&#xD;
      skinned individuals. The pathoetiology of vitiligo is multifactorial and has genetic,&#xD;
      immunological, and environmental components. Several environment-associated mechanisms have&#xD;
      been implicated to explain melanocyte disappearance, including ultraviolet (UV) radiation&#xD;
      exposure, repeated mechanical or thermal stress, and exposure to chemicals (especially&#xD;
      phenols or catechols), but epidemiologic data remain limited.&#xD;
&#xD;
      Broader gut dysbioses have been identified as potential causes or contributing factors to&#xD;
      human autoimmune diseases; however, human studies have not yet identified microbial&#xD;
      compositional or functional triggers that are predictive of skin autoimmunity or vitiligo.&#xD;
      Metabolites from intestinal microbiota are key determinants of host-microbe mutualism and,&#xD;
      consequently, the health or disease of the intestinal tract. However, whether such&#xD;
      host-microbe crosstalk influences inflammation in peripheral tissues, such as the skin, is&#xD;
      poorly understood.&#xD;
&#xD;
      The investigators will perform a metagenome association study and serum metabolomics&#xD;
      profiling in a cohort of vitiligo Chinese individuals.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 18, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Gut microbiota sequencing results by analyzing metagenomes of 16s rRNA gene or microbial genes</measure>
    <time_frame>2018.10.1--2019.3.1</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gut microbiota associated metabolic pathways by using metabolomics profiling of serum samples study</measure>
    <time_frame>2018.12.1--2019.3.1</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vitiligo associated activity measurements like VASI assays, serum markers detection</measure>
    <time_frame>2019.1--2019.3.1</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Gut Microbiome</condition>
  <arm_group>
    <arm_group_label>Disease</arm_group_label>
    <description>patients with vitiligo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Control</arm_group_label>
    <description>healthy control</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      the fecal and blood sample of recruited patients and healthy control volunteers&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        We recruit patients who have clinically advanced vitiligo, and barely have other diseases&#xD;
        which may disturb our study results.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects who volunteered and signed Informed Consent Form；&#xD;
&#xD;
          2. Male or female subjects 3-65 years of age；&#xD;
&#xD;
          3. Clinically confirmed the diagnosis of advanced vitiligo as per the diagnostic criteria&#xD;
             for vitiligo specified in Clinical Dermatology;&#xD;
&#xD;
          4. Stable vital signs.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who had taken systemic or local treatment with vitiligo in the last month;&#xD;
&#xD;
          2. Patients who had taken systemic antibiotics，systemic hormones，cytokines,&#xD;
             immunosuppressors in the previous three months;&#xD;
&#xD;
          3. The combination of other autoimmune diseases，gastrointestinal diseases, hepatic&#xD;
             diseases, psychiatric and psycho-related diseases, or other skin diseases;&#xD;
&#xD;
          4. The combination of Serious, life-threatening condition such as cardiac diseases, renal&#xD;
             diseases, endocrine system disease, cancer, or immunodeficiency diseases;&#xD;
&#xD;
          5. Women of child-bearing potential who are pregnant, plan to become pregnant during the&#xD;
             study or are lactating；&#xD;
&#xD;
          6. Any other condition that the investigator deems unsuitable for entering the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chunying Li</last_name>
    <role>Principal Investigator</role>
    <affiliation>Study Principal Investigator</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Qingrong Ni</last_name>
    <phone>15109230226</phone>
    <phone_ext>+86</phone_ext>
    <email>nitina.tn@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Xijing Hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xijing Hospital</last_name>
    </contact>
    <contact_backup>
      <last_name>Qingrong Ni</last_name>
      <phone>15109230226</phone>
      <phone_ext>+86</phone_ext>
      <email>nitina.tn@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 5, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>January 7, 2019</last_update_submitted>
  <last_update_submitted_qc>January 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Xijing Hospital</investigator_affiliation>
    <investigator_full_name>Li Chunying-1</investigator_full_name>
    <investigator_title>Vice Chief</investigator_title>
  </responsible_party>
  <keyword>Gut Microbiome</keyword>
  <keyword>Vitiligo</keyword>
  <keyword>Metabolic Pathways</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitiligo</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03797417
org study id: XJPF-LCY-V201812
nct id: NCT03797417
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Case-Control
time perspective: Prospective
measure: Gut microbiota sequencing results by analyzing metagenomes of 16s rRNA gene or microbial genes
time frame: 2018.10.1--2019.3.1
description: 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.
measure: Gut microbiota associated metabolic pathways by using metabolomics profiling of serum samples study
time frame: 2018.12.1--2019.3.1
description: 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.
measure: Vitiligo associated activity measurements like VASI assays, serum markers detection
time frame: 2019.1--2019.3.1
description: 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.
arm group label: Disease
description: patients with vitiligo
arm group label: Healthy Control
description: healthy control
the fecal and blood sample of recruited patients and healthy control volunteers
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 3 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Chunying Li
role: Principal Investigator
affiliation: Study Principal Investigator
last name: Qingrong Ni
phone: 15109230226
phone ext: +86
email: nitina.tn@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Xijing Hospital
investigator full name: Li Chunying-1
investigator title: Vice Chief
mesh term: Vitiligo
sharing ipd: Undecided