Effect of UGIR in Adults With Compromised Gut Function and Malabsorption

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome; Celiac Disease; Crohn Disease; Ulcerative Colitis
• Interventions: Other: Nutrition Support Product

• Registration Number: NCT03011593
• Lead Sponsor: Metagenics, Inc.

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 Timeline

• Study Start: 2015-11
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Study First Submitted: 2016-12-14
• Study First Submitted QC: 2017-01-03
• Study First Posted: 2017-01-05
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-04
• Last Update Posted: 2022-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nutrition Support Product	Nutrition Support Product	Participants were asked to take a nutrition support product twice per day for a period of 6 weeks.

Primary Outcome Measures

Name	Time	Method
Change in Gastrointestinal Quality of Life Index (GIQLI) Score	6 weeks

Secondary Outcome Measures

Name	Time	Method
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