<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/NCT03841045</url>
  </required_header>
  <id_info>
    <org_study_id>0148-15 SOR</org_study_id>
    <nct_id>NCT03841045</nct_id>
  </id_info>
  <brief_title>Unraveling a Potential Connection Between Bilirubin Metabolism, Gut Microbiota and Inflammatory Bowel Diseases</brief_title>
  <official_title>Unraveling a Potential Connection Between Bilirubin Metabolism, Gut Microbiota and Inflammatory Bowel Diseases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Soroka University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Soroka University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Inflammatory Bowel Diseases (IBDs) are a set of recurrent inflammatory conditions that&#xD;
      include the colon and small intestine. The two principal conditions include Crohn's disease&#xD;
      (CD) and ulcerative colitis (UC). The etiology of which is likely to stem from the interplay&#xD;
      of gut microbial imbalances and host. In this study stool cultures, saliva and skin samples&#xD;
      will be taken from all participants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recent studies have shown that certain CD patients harbor microbial communities that are&#xD;
      distinct from those of healthy individuals. These studies suggest a central role of the gut&#xD;
      microbial population in CD. The high complexity of the gut microbiome, which is the most&#xD;
      densely populated bacterial niche, makes the identification of these bacteria a significant&#xD;
      challenge. The bacterial population is comprised from 1013 - 1014 individuals, all belonging&#xD;
      roughly to a thousand different species, mostly anaerobic, and most of them (roughly 70% -&#xD;
      80%) are uncultivable.&#xD;
&#xD;
      The goals of this project are to examine a potential link between bilirubin metabolism and&#xD;
      IBD, by comparing fecal extracts from healthy humans and IBD patients, and to investigate the&#xD;
      underlying mechanism explaining these differences.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 14, 2016</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>change of bilirubin metabolism in fecal samples</measure>
    <time_frame>an average of 1 year after recruitment</time_frame>
    <description>liquid chromatography / mass spectrometric (LCMS) analysis is applied to bilirubin metabolism comparison between IBD patients and healthy humans in fecal extracts</description>
  </primary_outcome>
  <primary_outcome>
    <measure>microbial diversity of fecal matter</measure>
    <time_frame>an average of 1 year after recruitment</time_frame>
    <description>16S rRNA sequencing, is used to compare the microbial diversity between healthy individuals and IBD patients</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Colitis, Ulcerative</condition>
  <condition>Crohn Disease</condition>
  <arm_group>
    <arm_group_label>ulcerative colitis patient</arm_group_label>
    <description>people that have UC diagnosis can participate in the study. the disease can be at any level and the patients can handle any medications.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CD patient</arm_group_label>
    <description>people that have CD diagnosis can participate in the study. the disease can be at any label and the patients can handle any medications.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Health people</arm_group_label>
    <description>control group. no IBD patients can be included. patients with other diseases can be included.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      every enrolled people is asked to give saliva, skin and stool samples.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        people that have UC, CD diagnosis and healthy can participate in the study. the disease can&#xD;
        be at any level and the patients can handle any medications.&#xD;
&#xD;
        each participant will give fresh stool, saliva and skin samples during the study. only one&#xD;
        visit is planned in the study-for sighning ICF and returning samples.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  UC&#xD;
&#xD;
          -  CD&#xD;
&#xD;
          -  healthy Volunteers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • N/A&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ARIK SEGAL, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>SOROKA MC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>ARIK SEGAL, MD</last_name>
    <phone>972-50-7413471</phone>
    <email>ARIKSE@clalit.org.il</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>keren moyal, Ph.D</last_name>
    <phone>972-52-7129531</phone>
    <email>kerenmo@clalit.org.il</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>soroka MC</name>
      <address>
        <city>Be'er Sheva</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>keren moyal, phd</last_name>
      <phone>972-52-7129531</phone>
      <email>kerenmo@clalit.org.il</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>September 5, 2018</study_first_submitted>
  <study_first_submitted_qc>February 13, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>February 13, 2019</last_update_submitted>
  <last_update_submitted_qc>February 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Soroka University Medical Center</investigator_affiliation>
    <investigator_full_name>ARIK SEGAL MD</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
    <mesh_term>Colitis, Ulcerative</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03841045
org study id: 0148-15 SOR
nct id: NCT03841045
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Inflammatory Bowel Diseases (IBDs) are a set of recurrent inflammatory conditions that
      include the colon and small intestine. The two principal conditions include Crohn's disease
      (CD) and ulcerative colitis (UC). The etiology of which is likely to stem from the interplay
      of gut microbial imbalances and host. In this study stool cultures, saliva and skin samples
      will be taken from all participants.
Recent studies have shown that certain CD patients harbor microbial communities that are
      distinct from those of healthy individuals. These studies suggest a central role of the gut
      microbial population in CD. The high complexity of the gut microbiome, which is the most
      densely populated bacterial niche, makes the identification of these bacteria a significant
      challenge. The bacterial population is comprised from 1013 - 1014 individuals, all belonging
      roughly to a thousand different species, mostly anaerobic, and most of them (roughly 70% -
      80%) are uncultivable.

      The goals of this project are to examine a potential link between bilirubin metabolism and
      IBD, by comparing fecal extracts from healthy humans and IBD patients, and to investigate the
      underlying mechanism explaining these differences.
observational model: Cohort
time perspective: Prospective
measure: change of bilirubin metabolism in fecal samples
time frame: an average of 1 year after recruitment
description: liquid chromatography / mass spectrometric (LCMS) analysis is applied to bilirubin metabolism comparison between IBD patients and healthy humans in fecal extracts
measure: microbial diversity of fecal matter
time frame: an average of 1 year after recruitment
description: 16S rRNA sequencing, is used to compare the microbial diversity between healthy individuals and IBD patients
arm group label: ulcerative colitis patient
description: people that have UC diagnosis can participate in the study. the disease can be at any level and the patients can handle any medications.
arm group label: CD patient
description: people that have CD diagnosis can participate in the study. the disease can be at any label and the patients can handle any medications.
arm group label: Health people
description: control group. no IBD patients can be included. patients with other diseases can be included.
every enrolled people is asked to give saliva, skin and stool samples.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: ARIK SEGAL, MD
role: Principal Investigator
affiliation: SOROKA MC
last name: ARIK SEGAL, MD
phone: 972-50-7413471
email: ARIKSE@clalit.org.il
last name: keren moyal, Ph.D
phone: 972-52-7129531
email: kerenmo@clalit.org.il
facility: 
status: Recruiting
contact: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Soroka University Medical Center
investigator full name: ARIK SEGAL MD
investigator title: principal investigator
mesh term: Crohn Disease
mesh term: Inflammatory Bowel Diseases
mesh term: Colitis, Ulcerative
sharing ipd: No