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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Celiac Disease
• Crohn Disease
• Irritable Bowel Syndrome
• Malabsorption Syndromes
• Ulcerative Colitis

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

External Links

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