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Effect of UGIR in Adults With Compromised Gut Function and Malabsorption

Primary Purpose

Irritable Bowel Syndrome, Crohn Disease, Ulcerative Colitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nutrition Support Product
Sponsored by
Metagenics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Irritable Bowel Syndrome

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Body mass index 19 - 40 kg/m2
  • Previous diagnosis of ulcerative colitis (UC), Crohn's disease, irritable bowel syndrome (IBS), or celiac disease

Exclusion Criteria:

  • Gastroenterologic surgery within 3 months before the study period
  • Have a colostomy or ileostomy bag
  • Malignancy within the last 5 years
  • Women who are lactating, pregnant or planning pregnancy during the study period
  • Taking antibiotic, antiparasitic, or antifungal medications
  • Initiation of or changes to supplements or medications within 28 days prior to screening

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Nutrition Support Product

    Arm Description

    Participants were asked to take a nutrition support product twice per day for a period of 6 weeks.

    Outcomes

    Primary Outcome Measures

    Change in Gastrointestinal Quality of Life Index (GIQLI) Score

    Secondary Outcome Measures

    Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Score
    Change in Celiac Disease Questionnaire (CDQ) Score
    Change in Digestive Symptom Frequency Questionnaire (DSFQ) Score

    Full Information

    First Posted
    December 14, 2016
    Last Updated
    April 4, 2022
    Sponsor
    Metagenics, Inc.
    Collaborators
    National University of Natural Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03011593
    Brief Title
    Effect of UGIR in Adults With Compromised Gut Function and Malabsorption
    Official Title
    Effect of UGIR on Quality of Life in Adults With Compromised Gut Function and Malabsorption
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2015 (undefined)
    Primary Completion Date
    June 2016 (Actual)
    Study Completion Date
    June 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Metagenics, Inc.
    Collaborators
    National University of Natural Medicine

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study assessed the effect of a nutrition support product on quality of life in adults with compromised gut function and malabsorption.
    Detailed Description
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Irritable Bowel Syndrome, Crohn Disease, Ulcerative Colitis, Celiac Disease

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    18 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Nutrition Support Product
    Arm Type
    Experimental
    Arm Description
    Participants were asked to take a nutrition support product twice per day for a period of 6 weeks.
    Intervention Type
    Other
    Intervention Name(s)
    Nutrition Support Product
    Other Intervention Name(s)
    UGIR
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Change in Gastrointestinal Quality of Life Index (GIQLI) Score
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Score
    Time Frame
    6 weeks
    Title
    Change in Celiac Disease Questionnaire (CDQ) Score
    Time Frame
    6 weeks
    Title
    Change in Digestive Symptom Frequency Questionnaire (DSFQ) Score
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Body mass index 19 - 40 kg/m2 Previous diagnosis of ulcerative colitis (UC), Crohn's disease, irritable bowel syndrome (IBS), or celiac disease Exclusion Criteria: Gastroenterologic surgery within 3 months before the study period Have a colostomy or ileostomy bag Malignancy within the last 5 years Women who are lactating, pregnant or planning pregnancy during the study period Taking antibiotic, antiparasitic, or antifungal medications Initiation of or changes to supplements or medications within 28 days prior to screening
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nikhat Contractor, PhD
    Organizational Affiliation
    Metagenics, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    33799455
    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.
    Results Reference
    background
    Links:
    URL
    https://pubmed.ncbi.nlm.nih.gov/33799455/
    Description
    Related Info
    URL
    https://www.mdpi.com/2072-6643/13/3/938
    Description
    Related Info

    Learn more about this trial

    Effect of UGIR in Adults With Compromised Gut Function and Malabsorption

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