<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/NCT03011593</url>
  </required_header>
  <id_info>
    <org_study_id>UGIR</org_study_id>
    <nct_id>NCT03011593</nct_id>
  </id_info>
  <brief_title>Effect of UGIR in Adults With Compromised Gut Function and Malabsorption</brief_title>
  <official_title>Effect of UGIR on Quality of Life in Adults With Compromised Gut Function and Malabsorption</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Metagenics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National University of Natural Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Metagenics, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study assessed the effect of a nutrition support product on quality of life in adults&#xD;
      with compromised gut function and malabsorption.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective, non-randomized, open-label study assessed the effect of a nutrition support&#xD;
      product on quality of life in adults with compromised gut function and malabsorption. Adults&#xD;
      with irritable bowel syndrome (IBS), inflammatory bowel disease (IBD) or celiac disease were&#xD;
      enrolled in the study and asked to take the study product for 6 weeks. The primary measure of&#xD;
      the study was a validated quality of life questionnaire, the Gastrointestinal Quality of Life&#xD;
      Index (GIQLI). Secondary measures included the Inflammatory Bowel Disease Questionnaire&#xD;
      (IBDQ), the Celiac Disease Questionnaire (CDQ), and the Digestive Symptom Frequency&#xD;
      Questionnaire (DSFQ).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2015</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Gastrointestinal Quality of Life Index (GIQLI) Score</measure>
    <time_frame>6 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Score</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Celiac Disease Questionnaire (CDQ) Score</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Digestive Symptom Frequency Questionnaire (DSFQ) Score</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Irritable Bowel Syndrome</condition>
  <condition>Crohn Disease</condition>
  <condition>Ulcerative Colitis</condition>
  <condition>Celiac Disease</condition>
  <arm_group>
    <arm_group_label>Nutrition Support Product</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants were asked to take a nutrition support product twice per day for a period of 6 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nutrition Support Product</intervention_name>
    <description>Nutrition support product contains macronutrients, micronutrients, glutamine, and prebiotics. Product is in powder form (41 grams per serving) and is mixed with water or juice before consumption. Taken orally as a nutritional shake twice per day.</description>
    <arm_group_label>Nutrition Support Product</arm_group_label>
    <other_name>UGIR</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body mass index 19 - 40 kg/m2&#xD;
&#xD;
          -  Previous diagnosis of ulcerative colitis (UC), Crohn's disease, irritable bowel&#xD;
             syndrome (IBS), or celiac disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Gastroenterologic surgery within 3 months before the study period&#xD;
&#xD;
          -  Have a colostomy or ileostomy bag&#xD;
&#xD;
          -  Malignancy within the last 5 years&#xD;
&#xD;
          -  Women who are lactating, pregnant or planning pregnancy during the study period&#xD;
&#xD;
          -  Taking antibiotic, antiparasitic, or antifungal medications&#xD;
&#xD;
          -  Initiation of or changes to supplements or medications within 28 days prior to&#xD;
             screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nikhat Contractor, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Metagenics, Inc.</affiliation>
  </overall_official>
  <link>
    <url>https://pubmed.ncbi.nlm.nih.gov/33799455/</url>
    <description>Related Info</description>
  </link>
  <link>
    <url>https://www.mdpi.com/2072-6643/13/3/938</url>
    <description>Related Info</description>
  </link>
  <reference>
    <citation>Ryan JJ, Monteagudo-Mera A, Contractor N, Gibson GR. Impact of 2'-Fucosyllactose on Gut Microbiota Composition in Adults with Chronic Gastrointestinal Conditions: Batch Culture Fermentation Model and Pilot Clinical Trial Findings. Nutrients. 2021 Mar 14;13(3):938. doi: 10.3390/nu13030938.</citation>
    <PMID>33799455</PMID>
  </reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>April 4, 2022</last_update_submitted>
  <last_update_submitted_qc>April 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
    <mesh_term>Irritable Bowel Syndrome</mesh_term>
    <mesh_term>Celiac Disease</mesh_term>
    <mesh_term>Malabsorption Syndromes</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/NCT03011593
org study id: UGIR
nct id: NCT03011593
lead sponsor: 
collaborator: 
has dmc: No
This study assessed the effect of a nutrition support product on quality of life in adults
      with compromised gut function and malabsorption.
This prospective, non-randomized, open-label study assessed the effect of a nutrition support
      product on quality of life in adults with compromised gut function and malabsorption. Adults
      with irritable bowel syndrome (IBS), inflammatory bowel disease (IBD) or celiac disease were
      enrolled in the study and asked to take the study product for 6 weeks. The primary measure of
      the study was a validated quality of life questionnaire, the Gastrointestinal Quality of Life
      Index (GIQLI). Secondary measures included the Inflammatory Bowel Disease Questionnaire
      (IBDQ), the Celiac Disease Questionnaire (CDQ), and the Digestive Symptom Frequency
      Questionnaire (DSFQ).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in Gastrointestinal Quality of Life Index (GIQLI) Score
time frame: 6 weeks
measure: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Score
time frame: 6 weeks
measure: Change in Celiac Disease Questionnaire (CDQ) Score
time frame: 6 weeks
measure: Change in Digestive Symptom Frequency Questionnaire (DSFQ) Score
time frame: 6 weeks
arm group label: Nutrition Support Product
arm group type: Experimental
description: Participants were asked to take a nutrition support product twice per day for a period of 6 weeks.
intervention type: Other
intervention name: Nutrition Support Product
description: Nutrition support product contains macronutrients, micronutrients, glutamine, and prebiotics. Product is in powder form (41 grams per serving) and is mixed with water or juice before consumption. Taken orally as a nutritional shake twice per day.
arm group label: Nutrition Support Product
other name: UGIR
criteria: 
gender: All
minimum age: 21 Years
maximum age: 75 Years
healthy volunteers: No
last name: Nikhat Contractor, PhD
role: Study Director
affiliation: Metagenics, Inc.
url: https://pubmed.ncbi.nlm.nih.gov/33799455/
description: Related Info
url: https://www.mdpi.com/2072-6643/13/3/938
description: Related Info
citation: Ryan JJ, Monteagudo-Mera A, Contractor N, Gibson GR. Impact of 2'-Fucosyllactose on Gut Microbiota Composition in Adults with Chronic Gastrointestinal Conditions: Batch Culture Fermentation Model and Pilot Clinical Trial Findings. Nutrients. 2021 Mar 14;13(3):938. doi: 10.3390/nu13030938.
PMID: 33799455
responsible party type: Sponsor
mesh term: Crohn Disease
mesh term: Irritable Bowel Syndrome
mesh term: Celiac Disease
mesh term: Malabsorption Syndromes
sharing ipd: No