Effect of UGIR on Quality of Life in Adults With Compromised Gut Function and Malabsorption
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Metagenics, Inc.
- Enrollment
- 18
- Primary Endpoint
- Change in Gastrointestinal Quality of Life Index (GIQLI) Score
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Nutrition Support Product
Participants were asked to take a nutrition support product twice per day for a period of 6 weeks.
Intervention: Nutrition Support Product (Other)
Outcomes
Primary Outcomes
Change in Gastrointestinal Quality of Life Index (GIQLI) Score
Time Frame: 6 weeks
Secondary Outcomes
- Change in Digestive Symptom Frequency Questionnaire (DSFQ) Score(6 weeks)
- Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Score(6 weeks)
- Change in Celiac Disease Questionnaire (CDQ) Score(6 weeks)