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NCT03011593 Clinical Trial

Effect of UGIR in Adults With Compromised Gut Function and Malabsorption

Ulcerative Colitis Clinical Trial

Official title:
Effect of UGIR on Quality of Life in Adults With Compromised Gut Function and Malabsorption

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03011593
Other study ID # UGIR
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2015
Est. completion date June 2016

Study information
Verified date April 2022
Source Metagenics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender All
Age group 21 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Nutrition Support Product
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.

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Metagenics, Inc. National University of Natural Medicine

References & 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). pii: 938. doi: 10.3390/nu13030938. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Gastrointestinal Quality of Life Index (GIQLI) Score 6 weeks
Secondary Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Score 6 weeks
Secondary Change in Celiac Disease Questionnaire (CDQ) Score 6 weeks
Secondary Change in Digestive Symptom Frequency Questionnaire (DSFQ) Score 6 weeks
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