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Effect of UGIR in Adults With Compromised Gut Function and Malabsorption

M

Metagenics

Status

Completed

Conditions

Irritable Bowel Syndrome
Celiac Disease
Ulcerative Colitis
Crohn Disease

Treatments

Other: Nutrition Support Product

Study type

Interventional

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

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

Full 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).

Enrollment

18 patients

Sex

All

Ages

21 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

18 participants in 1 patient group

Nutrition Support Product
Experimental group
Description:
Participants were asked to take a nutrition support product twice per day for a period of 6 weeks.
Treatment:
Other: Nutrition Support Product

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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