<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/NCT03832439</url>
  </required_header>
  <id_info>
    <org_study_id>16-003300</org_study_id>
    <nct_id>NCT03832439</nct_id>
  </id_info>
  <brief_title>Probiotic Supplementation on Weight Loss</brief_title>
  <official_title>The Effect of Probiotic Supplementation on Weight Loss, and Its Association With the Gut Microbiome After Bariatric Surgery.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The investigators are trying to better understand how bariatric surgery leads to weight loss,&#xD;
      and the role of bacteria that live in the gut in making this happen.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators are interested in seeing how a probiotic, which is a dietary supplement&#xD;
      containing large amounts of 'good' bacteria, can influence the make-up of the gut bacterial&#xD;
      population and what effect it has on weight loss and loss of fat. Before undergoing weight&#xD;
      loss surgery (sleeve gastrectomy or roux-en-y gastric bypass), study participants will be&#xD;
      asked to provide a stool sample to assess the make-up of their gut bacterial population. They&#xD;
      will also undergo a limited CT scan of the abdomen and DEXA (Xray) to help assess the amount&#xD;
      of fat present inside the body.&#xD;
&#xD;
      After undergoing weight loss surgery (sleeve gastrectomy or roux-en-y gastric bypass), study&#xD;
      participants will be given either a probiotic supplement or dummy pill (placebo) for 3&#xD;
      months, in addition to all usual care that occurs after surgery. The CT scan, DEXA scan and&#xD;
      stool sample will be repeated at the end of the 3 month period and analyzed for changes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 17, 2019</start_date>
  <completion_date type="Actual">April 28, 2021</completion_date>
  <primary_completion_date type="Actual">April 28, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Weight loss</measure>
    <time_frame>3 months</time_frame>
    <description>Change in body weight from baseline to 3 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visceral fat loss</measure>
    <time_frame>3 months</time_frame>
    <description>Change in visceral fat from baseline to 3 months</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Bariatric Surgery Candidate</condition>
  <arm_group>
    <arm_group_label>Probiotic</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm will be receiving probiotic supplements.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>This arm will be receiving placebo containing microcrystalline cellulose.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Probiotic</intervention_name>
    <description>Lactobacillus rhamnosus GG 10 billion cells and microcrystalline cellulose</description>
    <arm_group_label>Probiotic</arm_group_label>
    <other_name>Culturelle®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>microcrystalline cellulose</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. All subjects who are &gt; 18 and &lt; 65 years of age recruited from the Mayo Clinic&#xD;
             bariatric surgery clinic&#xD;
&#xD;
          2. Will also meet one of the National Institute of Health's criteria for bariatric&#xD;
             surgery, i.e. body mass index (BMI) &gt; 40 kg/m2 or BMI &gt; 35 kg/m2 with significant&#xD;
             weight-related comorbidities.&#xD;
&#xD;
          3. Patients will be eligible if they are not on chronic antibiotic therapy and without&#xD;
             active systemic illness.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with type 1 or 2 diabetes will be excluded due to the known pre-existing&#xD;
             changes in the gut microbiome in this population. All patients will not have had&#xD;
             exposure to probiotics, prebiotics or antibiotics in the preceding 4 weeks.&#xD;
&#xD;
          2. Patients with allergy to antibiotics precluding the use of standard peri-operative&#xD;
             antibiotics (cefazolin and metronidazole) will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Meera Shah, M.B., Ch.B</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>February 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>February 18, 2022</last_update_submitted>
  <last_update_submitted_qc>February 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Meera Shah, M.B., Ch.B.</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Probiotic</keyword>
  <keyword>Microbiome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Weight Loss</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/NCT03832439
org study id: 16-003300
nct id: NCT03832439
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The investigators are trying to better understand how bariatric surgery leads to weight loss,
      and the role of bacteria that live in the gut in making this happen.
The investigators are interested in seeing how a probiotic, which is a dietary supplement
      containing large amounts of 'good' bacteria, can influence the make-up of the gut bacterial
      population and what effect it has on weight loss and loss of fat. Before undergoing weight
      loss surgery (sleeve gastrectomy or roux-en-y gastric bypass), study participants will be
      asked to provide a stool sample to assess the make-up of their gut bacterial population. They
      will also undergo a limited CT scan of the abdomen and DEXA (Xray) to help assess the amount
      of fat present inside the body.

      After undergoing weight loss surgery (sleeve gastrectomy or roux-en-y gastric bypass), study
      participants will be given either a probiotic supplement or dummy pill (placebo) for 3
      months, in addition to all usual care that occurs after surgery. The CT scan, DEXA scan and
      stool sample will be repeated at the end of the 3 month period and analyzed for changes.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Weight loss
time frame: 3 months
description: Change in body weight from baseline to 3 months
measure: Visceral fat loss
time frame: 3 months
description: Change in visceral fat from baseline to 3 months
arm group label: Probiotic
arm group type: Active Comparator
description: This arm will be receiving probiotic supplements.
arm group label: Placebo
arm group type: Placebo Comparator
description: This arm will be receiving placebo containing microcrystalline cellulose.
intervention type: Dietary Supplement
intervention name: Probiotic
description: Lactobacillus rhamnosus GG 10 billion cells and microcrystalline cellulose
arm group label: Probiotic
other name: Culturelle®
intervention type: Dietary Supplement
intervention name: microcrystalline cellulose
description: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Meera Shah, M.B., Ch.B
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Meera Shah, M.B., Ch.B.
investigator title: Principal Investigator
mesh term: Weight Loss
sharing ipd: No