<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/NCT04471077</url>
  </required_header>
  <id_info>
    <org_study_id>1072.6120.196.2018</org_study_id>
    <nct_id>NCT04471077</nct_id>
  </id_info>
  <brief_title>Association Between Outcomes of Bariatric Surgery and Preoperative Gastrointestinal Microbiota</brief_title>
  <official_title>Association Between Outcomes of Bariatric Surgery and Preoperative Gastrointestinal Microbiota</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jagiellonian University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jagiellonian University</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>
      Purpose The aim of this study was to analyze the microbiota of patients undergoing LSG or&#xD;
      LRYGB on three levels of gastrointestinal tract, using oral swab and stool sample. We&#xD;
      compared samples from patients achieving favorable outcomes in terms of weight-loss with&#xD;
      patients, who did not respond optimally to the bariatric operation.&#xD;
&#xD;
      Materials and methods Design This prospective cohort study was conducted in one academic,&#xD;
      teaching hospital. The recommendations of the Metabolic and Bariatric Surgery Section of the&#xD;
      Polish Surgical Society were used as indication for surgery, that is: Body Mass Index (BMI)&#xD;
      ≥35 kg/m2 with obesity-related comorbidities or BMI ≥40 kg/m2 .&#xD;
&#xD;
      Analysis and endpoints Primary endpoint was to determine the difference in microbiota present&#xD;
      in oral cavity and large intestine between patients ing Group 1 and Group 2. Secondary&#xD;
      endpoint was to compare the results of microbiota analysis between LSG and LRYGB.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Anticipated">December 30, 2020</completion_date>
  <primary_completion_date type="Actual">January 1, 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 microbiota in oral cavity</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of microbiota in large intestine</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Obesity, Morbid</condition>
  <arm_group>
    <arm_group_label>Favorable outcome of bariatric surgery</arm_group_label>
    <description>Excess weight loss above 50%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Unfavorable outcome of bariatric surgery</arm_group_label>
    <description>Excess weight loss below 50%</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>bariatric surgery</intervention_name>
    <description>(Laparoscopic Sleeve Gastrectomy, laparoscopic Roux-en-Y gastric bypass)</description>
    <arm_group_label>Favorable outcome of bariatric surgery</arm_group_label>
    <arm_group_label>Unfavorable outcome of bariatric surgery</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The investigators included patients undergoing surgical treatment for morbid obesity.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  informed consent to participate in the study, meeting the eligibility criteria for&#xD;
             bariatric treatment, either for LSG or LRYGB.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  type 1 or type 2 diabetes, treatment with antibiotics within 30 days prior to&#xD;
             gathering microbiological material, treatment with probiotics within 30 days prior to&#xD;
             gathering microbiological material, gastrointestinal infections, inflammatory bowel&#xD;
             disease, thyroid diseases, cancer (especially the digestive tract), immunodeficiency.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>2nd Department of General Surgery, Jagiellonian University Medical College</name>
      <address>
        <city>Cracovia</city>
        <state>Małopolska</state>
        <zip>30-688</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>July 14, 2020</last_update_submitted>
  <last_update_submitted_qc>July 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jagiellonian University</investigator_affiliation>
    <investigator_full_name>Tomasz Stefura</investigator_full_name>
    <investigator_title>Reasearch Associate, PhD student at 2nd Department of General Surgery, Principal Investigator, Medical Doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity, Morbid</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We are not planing to share data.</ipd_description>
  </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/NCT04471077
org study id: 1072.6120.196.2018
nct id: NCT04471077
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Purpose The aim of this study was to analyze the microbiota of patients undergoing LSG or
      LRYGB on three levels of gastrointestinal tract, using oral swab and stool sample. We
      compared samples from patients achieving favorable outcomes in terms of weight-loss with
      patients, who did not respond optimally to the bariatric operation.

      Materials and methods Design This prospective cohort study was conducted in one academic,
      teaching hospital. The recommendations of the Metabolic and Bariatric Surgery Section of the
      Polish Surgical Society were used as indication for surgery, that is: Body Mass Index (BMI)
      ≥35 kg/m2 with obesity-related comorbidities or BMI ≥40 kg/m2 .

      Analysis and endpoints Primary endpoint was to determine the difference in microbiota present
      in oral cavity and large intestine between patients ing Group 1 and Group 2. Secondary
      endpoint was to compare the results of microbiota analysis between LSG and LRYGB.
observational model: Cohort
time perspective: Prospective
measure: Change of microbiota in oral cavity
time frame: 6 months
measure: Change of microbiota in large intestine
time frame: 6 months
arm group label: Favorable outcome of bariatric surgery
description: Excess weight loss above 50%
arm group label: Unfavorable outcome of bariatric surgery
description: Excess weight loss below 50%
intervention type: Procedure
intervention name: bariatric surgery
description: (Laparoscopic Sleeve Gastrectomy, laparoscopic Roux-en-Y gastric bypass)
arm group label: Favorable outcome of bariatric surgery
arm group label: Unfavorable outcome of bariatric surgery
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
facility: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Jagiellonian University
investigator full name: Tomasz Stefura
investigator title: Reasearch Associate, PhD student at 2nd Department of General Surgery, Principal Investigator, Medical Doctor
mesh term: Obesity, Morbid
sharing ipd: No
ipd description: We are not planing to share data.