<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/NCT04495972</url>
  </required_header>
  <id_info>
    <org_study_id>DM Prevent POC</org_study_id>
    <nct_id>NCT04495972</nct_id>
  </id_info>
  <brief_title>Intestinimonas for Prevention of Type 2 Diabetes Mellitus</brief_title>
  <official_title>Novel Intestinal Microbiota-based Product for Preventing Type 2 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Caelus Pharmaceuticals BV</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Caelus Pharmaceuticals BV</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>
      The study aims to assess the effects of a microbiota-based product containing Intestinimonas&#xD;
      in adults with pre-diabetes. The purpose is to determine the safety and efficacy of the&#xD;
      microbiota-based product on insulin sensitivity in a target group of prediabetic individuals.&#xD;
      In particular, the objective is to evaluate whether Intestinimonas is able to improve the&#xD;
      insulin sensitivity, the response to the oral glucose tolerance test (OGTT) and whether it is&#xD;
      able to modulate the microbiota composition in the study subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study aims to assess the effects of a microbiota-based product containing Intestinimonas&#xD;
      in adults with pre-diabetes.&#xD;
&#xD;
      Intestinimonas is an aerobic microorganism which produces butyrate and interacts with the&#xD;
      local microbiota in small and large intestine.&#xD;
&#xD;
      In preclinical studies, it was demonstrated that the insulin sensitivity can be enhanced by&#xD;
      Intestinimonas and similar microbiota.&#xD;
&#xD;
      The purpose is to determine the safety and efficacy of the microbiota-based product on&#xD;
      insulin sensitivity in a target group of prediabetic individuals.&#xD;
&#xD;
      The study participants will be subjects who are overweight and are at risk of developing Type&#xD;
      2 diabetes.&#xD;
&#xD;
      The key objective of this randomized, placebo-controlled study is to evaluate whether&#xD;
      Intestinimonas is able to improve the insulin sensitivity, to assess the response to the oral&#xD;
      glucose tolerance test (OGTT) and whether it is able to modulate the microbiota composition&#xD;
      in the study subjects.&#xD;
&#xD;
      Furthermore, in a open-label follow-up of 14 weeks the effect of a high-dose of&#xD;
      Intestinimonas will be compared with the low-dose tested in the initial double-blind&#xD;
      Randomised Controlled Trial (RCT).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 15, 2021</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">September 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <intervention_model_description>Double-blind, randomized, placebo-controlled study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Insulin sensitivity</measure>
    <time_frame>12 weeks</time_frame>
    <description>as measured by Homeostatic Model Assessment (HOMA) - index</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Concentration of Fasting glucose</measure>
    <time_frame>12 weeks</time_frame>
    <description>as measured by Glucose in plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of 2-hour blood glucose Area Under the Curve (AUC)</measure>
    <time_frame>12 weeks</time_frame>
    <description>as measured by standard Oral Glucose Tolerance Test (OGTT)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">26</enrollment>
  <condition>PreDiabetes</condition>
  <arm_group>
    <arm_group_label>Experimental arm: Intestinimonas</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intestinimonas in capsules</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo arm: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo in capsules</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Intestinimonas-capsules</intervention_name>
    <description>Capsules containing microbiota (Intestinimonas)</description>
    <arm_group_label>Experimental arm: Intestinimonas</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo-capsules</intervention_name>
    <description>Placebo capsules are identical to the active treatment</description>
    <arm_group_label>Placebo arm: Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  increased BMI &gt; 25,&#xD;
&#xD;
          -  Fasting Plasma Glucose (FPG) 100-125 mg/dl or glucose &gt; 140 after OGTT, or HbA1c 5.7%&#xD;
             - 6.4%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Type 2 diabetes&#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_contact>
    <last_name>Luc Sterkman, MD</last_name>
    <phone>+31622979249</phone>
    <email>l.sterkman@caelushealth.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Piemonte Orientale</name>
      <address>
        <city>Vercelli</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Flavia Prodam, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>February 14, 2023</last_update_submitted>
  <last_update_submitted_qc>February 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prediabetic State</keyword>
  <keyword>Metabolic Syndrome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <!-- 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/NCT04495972
org study id: DM Prevent POC
nct id: NCT04495972
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study aims to assess the effects of a microbiota-based product containing Intestinimonas
      in adults with pre-diabetes. The purpose is to determine the safety and efficacy of the
      microbiota-based product on insulin sensitivity in a target group of prediabetic individuals.
      In particular, the objective is to evaluate whether Intestinimonas is able to improve the
      insulin sensitivity, the response to the oral glucose tolerance test (OGTT) and whether it is
      able to modulate the microbiota composition in the study subjects.
The study aims to assess the effects of a microbiota-based product containing Intestinimonas
      in adults with pre-diabetes.

      Intestinimonas is an aerobic microorganism which produces butyrate and interacts with the
      local microbiota in small and large intestine.

      In preclinical studies, it was demonstrated that the insulin sensitivity can be enhanced by
      Intestinimonas and similar microbiota.

      The purpose is to determine the safety and efficacy of the microbiota-based product on
      insulin sensitivity in a target group of prediabetic individuals.

      The study participants will be subjects who are overweight and are at risk of developing Type
      2 diabetes.

      The key objective of this randomized, placebo-controlled study is to evaluate whether
      Intestinimonas is able to improve the insulin sensitivity, to assess the response to the oral
      glucose tolerance test (OGTT) and whether it is able to modulate the microbiota composition
      in the study subjects.

      Furthermore, in a open-label follow-up of 14 weeks the effect of a high-dose of
      Intestinimonas will be compared with the low-dose tested in the initial double-blind
      Randomised Controlled Trial (RCT).
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: Double-blind, randomized, placebo-controlled study
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Insulin sensitivity
time frame: 12 weeks
description: as measured by Homeostatic Model Assessment (HOMA) - index
measure: Concentration of Fasting glucose
time frame: 12 weeks
description: as measured by Glucose in plasma
measure: Level of 2-hour blood glucose Area Under the Curve (AUC)
time frame: 12 weeks
description: as measured by standard Oral Glucose Tolerance Test (OGTT)
arm group label: Experimental arm: Intestinimonas
arm group type: Active Comparator
description: Intestinimonas in capsules
arm group label: Placebo arm: Placebo
arm group type: Placebo Comparator
description: Placebo in capsules
intervention type: Dietary Supplement
intervention name: Intestinimonas-capsules
description: Capsules containing microbiota (Intestinimonas)
arm group label: Experimental arm: Intestinimonas
intervention type: Dietary Supplement
intervention name: Placebo-capsules
description: Placebo capsules are identical to the active treatment
arm group label: Placebo arm: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Luc Sterkman, MD
phone: +31622979249
email: l.sterkman@caelushealth.com
facility: 
status: Recruiting
contact: 
country: Italy
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2