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CompletedNCT03011593Updated Apr 6, 2022

Effect of UGIR in Adults With Compromised Gut Function and Malabsorption

An interventional study of Nutrition Support Product in Irritable Bowel Syndrome, Crohn Disease and Ulcerative Colitis, sponsored by Metagenics, Inc.. Completed. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-04-06.

Sponsored by Metagenics, Inc. · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Not applicable
Ages
21 Years to 75 Years
Sex
All
01

Study summary

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

Read the 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).

02

Conditions studied

  • Irritable Bowel Syndrome
  • Crohn Disease
  • Ulcerative Colitis
  • Celiac Disease
03

Who can participate

Ages eligible
21 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • 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

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.

    Also known as: UGIR

05

What researchers measure

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

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • Ryan JJ, Monteagudo-Mera A, Contractor N, Gibson GR. Impact of 2'-Fucosyllactose on Gut Microbiota Composition in Adults with Chronic Gastrointestinal Conditions: Batch Culture Fermentation Model and Pilot Clinical Trial Findings. Nutrients. 2021 Mar 14;13(3):938. doi: 10.3390/nu13030938. PubMed 33799455 ↗

Related links

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03011593
Lead sponsor
Metagenics, Inc.
Collaborators
National University of Natural Medicine
Responsible party
Sponsor
First posted
Jan 5, 2017
Start date
Nov 2015
Primary completion
Jun 2016
Completion
Jun 2016
Last update
Apr 6, 2022

Study contacts

Nikhat Contractor, PhD
study director · Metagenics, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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