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
About this trial
This is an interventional supportive care trial for Irritable Bowel Syndrome
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
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
NCT ID
NCT03011593
First Posted
December 14, 2016
Last Updated
April 4, 2022
Sponsor
Metagenics, Inc.
Collaborators
National University of Natural Medicine
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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