Effect of UGIR in Adults With Compromised Gut Function and Malabsorption

Metagenics, Inc.18 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Irritable Bowel Syndrome Crohn Disease Ulcerative Colitis Celiac Disease

Interventions

Nutrition Support ProductOTHER

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

Sex: ALLMin age: 21 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in Gastrointestinal Quality of Life Index (GIQLI) Score

Time frame: 6 weeks

Secondary Outcomes

Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Score

Time frame: 6 weeks

Change in Celiac Disease Questionnaire (CDQ) Score

Time frame: 6 weeks

Change in Digestive Symptom Frequency Questionnaire (DSFQ) Score

Time frame: 6 weeks

Data from ClinicalTrials.gov

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