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Completed

NCT Number: NCT03011593

Effect of UGIR in Adults With Compromised Gut Function and Malabsorption

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

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Key information

Conditions

Irritable Bowel Syndrome Celiac Disease Colitis Colitis, Ulcerative Colonic Diseases Colonic Diseases, Functional Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases Ulcerative Colitis

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutrition support product

Other

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.

Other names: UGIR

Primary outcomes

  1. Change in Gastrointestinal Quality of Life Index (GIQLI) Score

    Time frame: 6 weeks

Secondary outcomes

  1. Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Score

    Time frame: 6 weeks

  2. Change in Celiac Disease Questionnaire (CDQ) Score

    Time frame: 6 weeks

  3. Change in Digestive Symptom Frequency Questionnaire (DSFQ) Score

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Metagenics, Inc.

Industry

Collaborators

  • National University of Natural Medicine

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 5, 2017
Registry last updated
Apr 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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