<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/NCT04489329</url>
  </required_header>
  <id_info>
    <org_study_id>REB 20-1211</org_study_id>
    <nct_id>NCT04489329</nct_id>
  </id_info>
  <brief_title>Dietary Intervention Detection in the Small Intestine</brief_title>
  <official_title>Use of the Small Intestine Microbiome Aspiration (SIMBA) Capsule to Detect a Dietary Intervention in the Small Intestine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nimble Science Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Calgary</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Lallemand Health Solutions</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Nimble Science Ltd.</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>
      Proof of concept study to validate the ability of a capsule device to gather samples from the&#xD;
      small bowel for microbiome analysis in adults and to detect dietary changes from simultaneous&#xD;
      ingestion of a probiotic.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 22, 2020</start_date>
  <completion_date type="Actual">February 24, 2021</completion_date>
  <primary_completion_date type="Actual">February 24, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bacterial density count</measure>
    <time_frame>7 days</time_frame>
    <description>density count of probiotic strain compared between capsule and stool sample (CFU/ml)</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Proof of Concept</condition>
  <arm_group>
    <arm_group_label>Single Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participant swallows and retrieves capsule in stool before and after ingestion of a probiotic. Capsule and stool samples are analyzed for presence of probiotic strain and compared to baseline.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ingestible Capsule</intervention_name>
    <description>Participants will swallow capsule and undergo X-rays to establish transit</description>
    <arm_group_label>Single Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Probiotic</intervention_name>
    <description>Participants will swallow a probiotic capsule and the sample collection capsule at the same time to establish concentration of strain in small intestine.</description>
    <arm_group_label>Single Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18 to 65 years old&#xD;
&#xD;
          2. Healthy&#xD;
&#xD;
          3. On no medication, or on stable doses of medications which will not be changed over the&#xD;
             course of the study&#xD;
&#xD;
          4. Willingness to maintain their usual dietary habits and physical activity&#xD;
&#xD;
          5. Willing to discontinue consumption of fermented foods or probiotics (such as kombucha,&#xD;
             yogurts with live, active cultures, or probiotic supplements) for the duration of the&#xD;
             study.&#xD;
&#xD;
          6. Ability to understand and provide informed consent&#xD;
&#xD;
          7. Ability and willingness to meet the required schedule and study tasks and&#xD;
             interventions&#xD;
&#xD;
          8. Willing to fast for at least 8 hours before the 2 intake visits (Visit 1 and Visit 2)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of a small intestine obstruction of symptoms of an intermittent small&#xD;
             intestine obstruction (i.e., recurrent abdominal pain, distention, nausea and&#xD;
             vomiting).&#xD;
&#xD;
          2. Pregnant or breastfeeding or planning on becoming pregnant during study timeline.&#xD;
&#xD;
          3. Use of other investigational product within 3 months of start of the study.&#xD;
&#xD;
          4. Suffering from immune disorders or with possible immune deficient status&#xD;
&#xD;
          5. Allergy to soy or milk.&#xD;
&#xD;
          6. Prior gastrointestinal surgery which has altered the anatomy of the esophagus, stomach&#xD;
             or small or large intestine (exceptions include appendectomy or cholecystectomy more&#xD;
             than 3 months prior to enrollment).&#xD;
&#xD;
          7. Use of any medications in the previous 7 days that could substantially alter&#xD;
             gastrointestinal motor function (e.g. opioids, prokinetics, anticholinergics,&#xD;
             laxatives), acidity (PPI, H2RA), or integrity (NSAIDs, oral steroids).&#xD;
&#xD;
          8. Body Mass Index (BMI) &gt; 38.&#xD;
&#xD;
          9. Previous history of gastric bezoar or gastroparesis.&#xD;
&#xD;
         10. Any abdominal or pelvic surgery within the past 3 months.&#xD;
&#xD;
         11. Known history of inflammatory bowel disease and/or Crohn's disease.&#xD;
&#xD;
         12. History of diverticulitis, diverticular stricture, or other intestinal strictures.&#xD;
&#xD;
         13. History of abdominal or pelvic radiotherapy.&#xD;
&#xD;
         14. History of dysphagia, eosinophilic esophagitis, esophageal stricture, or other&#xD;
             swallowing disorder.&#xD;
&#xD;
         15. Cardiovascular, endocrine, renal or other chronic disease likely to affect motility.&#xD;
&#xD;
         16. Colon cleansing prep for 1 month before the first visit, or during the study.&#xD;
&#xD;
         17. Use of antibiotics, prebiotics, herbal supplements, or probiotics for 2 weeks before&#xD;
             the first visit, or during the study.&#xD;
&#xD;
         18. &lt; 2 bowel movements per week.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chris Andrews, MD MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Calgary</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cumming School of Medicine</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 4Z6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>September 6, 2021</last_update_submitted>
  <last_update_submitted_qc>September 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04489329
org study id: REB 20-1211
nct id: NCT04489329
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Proof of concept study to validate the ability of a capsule device to gather samples from the
      small bowel for microbiome analysis in adults and to detect dietary changes from simultaneous
      ingestion of a probiotic.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Bacterial density count
time frame: 7 days
description: density count of probiotic strain compared between capsule and stool sample (CFU/ml)
arm group label: Single Arm
arm group type: Experimental
description: Participant swallows and retrieves capsule in stool before and after ingestion of a probiotic. Capsule and stool samples are analyzed for presence of probiotic strain and compared to baseline.
intervention type: Device
intervention name: Ingestible Capsule
description: Participants will swallow capsule and undergo X-rays to establish transit
arm group label: Single Arm
intervention type: Dietary Supplement
intervention name: Probiotic
description: Participants will swallow a probiotic capsule and the sample collection capsule at the same time to establish concentration of strain in small intestine.
arm group label: Single Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Chris Andrews, MD MSc
role: Principal Investigator
affiliation: University of Calgary
facility: 
country: Canada
responsible party type: Sponsor
sharing ipd: No