Effect of UGIR in Adults With Compromised Gut Function and Malabsorption
Effect of UGIR on Quality of Life in Adults With Compromised Gut Function and Malabsorption
1 other identifier
interventional
18
0 countries
N/A
Brief Summary
This study assessed the effect of a nutrition support product on quality of life in adults with compromised gut function and malabsorption.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2015
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 14, 2016
CompletedFirst Posted
Study publicly available on registry
January 5, 2017
CompletedApril 6, 2022
April 1, 2022
7 months
December 14, 2016
April 4, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Gastrointestinal Quality of Life Index (GIQLI) Score
6 weeks
Secondary Outcomes (3)
Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Score
6 weeks
Change in Celiac Disease Questionnaire (CDQ) Score
6 weeks
Change in Digestive Symptom Frequency Questionnaire (DSFQ) Score
6 weeks
Study Arms (1)
Nutrition Support Product
EXPERIMENTALParticipants were asked to take a nutrition support product twice per day for a period of 6 weeks.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Body mass index 19 - 40 kg/m2
- Previous diagnosis of ulcerative colitis (UC), Crohn's disease, irritable bowel syndrome (IBS), or celiac disease
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Metagenics, Inc.lead
- National University of Natural Medicinecollaborator
Related Publications (1)
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: 33799455BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Nikhat Contractor, PhD
Metagenics, Inc.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2016
First Posted
January 5, 2017
Study Start
November 1, 2015
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
April 6, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share