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Effect of UGIR in Adults With Compromised Gut Function and Malabsorption

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ClinicalTrials.gov Identifier: NCT03011593
Recruitment Status : Completed
First Posted : January 5, 2017
Last Update Posted : January 5, 2017
Sponsor:
Collaborator:
National University of Natural Medicine
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Crohn Disease Ulcerative Colitis Celiac Disease Other: Nutrition Support Product Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effect of UGIR on Quality of Life in Adults With Compromised Gut Function and Malabsorption
Study Start Date : November 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Nutrition Support Product
Participants were asked to take a nutrition support product twice per day for a period of 6 weeks.
Other: Nutrition 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.
Other Name: UGIR



Primary Outcome Measures :
  1. Change in Gastrointestinal Quality of Life Index (GIQLI) Score [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03011593


Sponsors and Collaborators
Metagenics, Inc.
National University of Natural Medicine
Investigators
Study Director: Nikhat Contractor, PhD Metagenics, Inc.

Responsible Party: Metagenics, Inc.
ClinicalTrials.gov Identifier: NCT03011593     History of Changes
Other Study ID Numbers: UGIR
First Posted: January 5, 2017    Key Record Dates
Last Update Posted: January 5, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Crohn Disease
Colitis, Ulcerative
Irritable Bowel Syndrome
Celiac Disease
Malabsorption Syndromes
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colitis
Colonic Diseases
Colonic Diseases, Functional
Metabolic Diseases