Effect of UGIR in Adults With Compromised Gut Function and Malabsorption

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

Detailed Description
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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).

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

Conditions
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Irritable Bowel Syndrome, Crohn Disease, Ulcerative Colitis, Celiac Disease

Intervention / Treatment
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* Other: Nutrition Support Product


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutrition Support Product<br>Participants were asked to take a nutrition support product twice per day for a period of 6 weeks. | Other: Nutrition Support Product<br>* 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.<br>* Other names: UGIR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Gastrointestinal Quality of Life Index (GIQLI) Score |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |