Effect of UGIR in Adults With Compromised Gut Function and Malabsorption

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03011593

Enrollment

Registered

2017-01-05

Start date

2015-11-30

Completion date

2016-06-30

Last updated

2022-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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).

Interventions

OTHERNutrition 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in Gastrointestinal Quality of Life Index (GIQLI) Score	6 weeks

Secondary

Measure	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026