<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/NCT04489836</url>
  </required_header>
  <id_info>
    <org_study_id>Project 0470-Pilot study</org_study_id>
    <nct_id>NCT04489836</nct_id>
  </id_info>
  <brief_title>GlutDigest - Pilot Study</brief_title>
  <acronym>GlutDigestP</acronym>
  <official_title>GlutDigest - Enzymes-assisted Gluten Digestion (Pilot Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Deerland Enzymes</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Teagasc</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Atlantia Food Clinical Trials</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Deerland Enzymes</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>
      This is a pilot, feasibility study to evaluate, test and optimize sample analysis procedures&#xD;
      and protocols before the full-scale, crossover study is conducted.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Two important factors can influence the proportions of gluten and starch that resist&#xD;
      digestion: (1) enzyme availability and specificity and (2) the structural properties of the&#xD;
      food. A complete evaluation of gluten digestion and of the impact of dietary supplements is&#xD;
      difficult to conduct because it is not easy to obtain samples of digestive chime. The&#xD;
      analysis of the ileal effluent of healthy ileostomy patients constitutes a non-invasive&#xD;
      alternative to intubation techniques for the study of nutrient digestion and of the fate of&#xD;
      probiotics in the small intestine.&#xD;
&#xD;
      The main aim of this study is to test and optimize sample analysis protocols before&#xD;
      conducting the full-scale, crossover study which will aim at evaluating the impact of two&#xD;
      dietary supplements (Glutalytic® and DE111®) and of oatmeal properties on the digestion of&#xD;
      gluten and starch and on the glycemic response.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 31, 2020</start_date>
  <completion_date type="Actual">September 19, 2020</completion_date>
  <primary_completion_date type="Actual">September 19, 2020</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>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Undigested wheat protein after each treatment</measure>
    <time_frame>9-hour period after the test meal</time_frame>
    <description>Difference between the mean concentration of undigested wheat protein in ileal effluent samples.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Vegetative DE111 cells</measure>
    <time_frame>9-hour period after the test meal</time_frame>
    <description>Mean concentration of DE111® cells recovered in the ileal effluent samples.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic response</measure>
    <time_frame>At baseline, and at different time-points in the 9-hour period after consumption of the test meal.</time_frame>
    <description>Difference between the mean area under the glucose concentration (measured in the interstitial fluid) curves following each treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Undigested starch</measure>
    <time_frame>9-hour period after the test meal</time_frame>
    <description>Difference between the mean concentration of undigested starch in ileal effluent samples.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Undigested food particles</measure>
    <time_frame>9-hour period after the test meal</time_frame>
    <description>Pictures of undigested foods particles and microscopy will be combined for a combined assessment of macro- and micro- structural characteristics of the food particles recovered in ileal effluent samples.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Main Focus: Gluten and Starch Digestibility</condition>
  <arm_group>
    <arm_group_label>Meal A + Glutalytic®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>350 mg Glutalytic® capsule, taken by mouth, once, with Meal A</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Meal A + DE111®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>350 mg DE111® capsule, taken by mouth, once, with Meal A</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Glutalytic®</intervention_name>
    <description>Glutalytic® capsule</description>
    <arm_group_label>Meal A + Glutalytic®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>DE111®</intervention_name>
    <description>DE111® capsule</description>
    <arm_group_label>Meal A + DE111®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Meal A</intervention_name>
    <description>Oatmeal porridge - serving of oat porridge (cooked) containing 50g of carbohydrates (excluding sugars); Wheat cereal - serving of wheat cereal providing 1g of gluten; Water - 125 mL</description>
    <arm_group_label>Meal A + DE111®</arm_group_label>
    <arm_group_label>Meal A + Glutalytic®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject has given written informed consent&#xD;
&#xD;
          -  Subject has an ileostomy stable for at least 3 months post-operative and shows normal&#xD;
             stoma functions&#xD;
&#xD;
          -  Subject is otherwise healthy&#xD;
&#xD;
          -  Subject is available to participate in the study sessions on the proposed dates&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has coeliac disease or allergy to wheat products and/or any other ingredients&#xD;
             in the test meal and standard meals&#xD;
&#xD;
          -  Case of obstruction of the stoma in the past 3 months&#xD;
&#xD;
          -  Body mass index &lt; 18 kg/m2 or &gt; 30 kg/m2.&#xD;
&#xD;
          -  Diagnosed mouth, throat or active gastrointestinal pathology (other than ileostomy)&#xD;
             that may affect normal ingestion and digestion of food.&#xD;
&#xD;
          -  History of pancreatic disease&#xD;
&#xD;
          -  Subject is immunocompromised (HIV positive, transplant patient, on antirejection&#xD;
             medications, on a steroid for &gt;30 days, or chemotherapy or radiotherapy within the&#xD;
             last year)&#xD;
&#xD;
          -  Subject has Type 1 or Type 2 diabetes mellitus.&#xD;
&#xD;
          -  Subject has a history of bariatric surgery.&#xD;
&#xD;
          -  Subject has a history of drug and/or alcohol abuse at the time of enrolment&#xD;
&#xD;
          -  Subject is currently participating in another study, or plans to participate in&#xD;
             another study during the study period&#xD;
&#xD;
          -  Women of child-bearing potential who do not use an acceptable method of contraception&#xD;
&#xD;
          -  Pregnant or nursing (lactating) women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Atlantia Food Clinical Trials</name>
      <address>
        <city>Cork</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ireland</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>October 22, 2020</last_update_submitted>
  <last_update_submitted_qc>October 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gluten</keyword>
  <keyword>Starch</keyword>
  <keyword>Digestive enzymes</keyword>
  <keyword>Probiotics</keyword>
  <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/NCT04489836
org study id: Project 0470-Pilot study
nct id: NCT04489836
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a pilot, feasibility study to evaluate, test and optimize sample analysis procedures
      and protocols before the full-scale, crossover study is conducted.
Two important factors can influence the proportions of gluten and starch that resist
      digestion: (1) enzyme availability and specificity and (2) the structural properties of the
      food. A complete evaluation of gluten digestion and of the impact of dietary supplements is
      difficult to conduct because it is not easy to obtain samples of digestive chime. The
      analysis of the ileal effluent of healthy ileostomy patients constitutes a non-invasive
      alternative to intubation techniques for the study of nutrient digestion and of the fate of
      probiotics in the small intestine.

      The main aim of this study is to test and optimize sample analysis protocols before
      conducting the full-scale, crossover study which will aim at evaluating the impact of two
      dietary supplements (Glutalytic® and DE111®) and of oatmeal properties on the digestion of
      gluten and starch and on the glycemic response.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: Undigested wheat protein after each treatment
time frame: 9-hour period after the test meal
description: Difference between the mean concentration of undigested wheat protein in ileal effluent samples.
measure: Vegetative DE111 cells
time frame: 9-hour period after the test meal
description: Mean concentration of DE111® cells recovered in the ileal effluent samples.
measure: Glycemic response
time frame: At baseline, and at different time-points in the 9-hour period after consumption of the test meal.
description: Difference between the mean area under the glucose concentration (measured in the interstitial fluid) curves following each treatment.
measure: Undigested starch
time frame: 9-hour period after the test meal
description: Difference between the mean concentration of undigested starch in ileal effluent samples.
measure: Undigested food particles
time frame: 9-hour period after the test meal
description: Pictures of undigested foods particles and microscopy will be combined for a combined assessment of macro- and micro- structural characteristics of the food particles recovered in ileal effluent samples.
arm group label: Meal A + Glutalytic®
arm group type: Experimental
description: 350 mg Glutalytic® capsule, taken by mouth, once, with Meal A
arm group label: Meal A + DE111®
arm group type: Experimental
description: 350 mg DE111® capsule, taken by mouth, once, with Meal A
intervention type: Dietary Supplement
intervention name: Glutalytic®
description: Glutalytic® capsule
arm group label: Meal A + Glutalytic®
intervention type: Dietary Supplement
intervention name: DE111®
description: DE111® capsule
arm group label: Meal A + DE111®
intervention type: Other
intervention name: Meal A
description: Oatmeal porridge - serving of oat porridge (cooked) containing 50g of carbohydrates (excluding sugars); Wheat cereal - serving of wheat cereal providing 1g of gluten; Water - 125 mL
arm group label: Meal A + DE111®
arm group label: Meal A + Glutalytic®
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Ireland
responsible party type: Sponsor
sharing ipd: No