Irritable Bowel SyndromeNCT03011593
Effect of UGIR in Adults With Compromised Gut Function and Malabsorption
A study testing Nutrition Support Product in people with Irritable Bowel Syndrome and Crohn Disease, run by Metagenics, Inc..
Trial summary
This study assessed the effect of a nutrition support product on quality of life in adults with compromised gut function and malabsorption. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Irritable Bowel Syndrome, Crohn Disease, Ulcerative Colitis
- What is being tested?
- Nutrition Support Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index 19 - 40 kg/m2
- Previous diagnosis of ulcerative colitis (UC), Crohn's disease, irritable bowel syndrome (IBS), or celiac disease
Who cannot join
- 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
About this study
Official title: Effect of UGIR on Quality of Life 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.
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).
- Being tested
- Nutrition Support Product
- Medical subject headings
- Irritable Bowel Syndrome, Crohn Disease, Colitis, Ulcerative, Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition Support ProductOther
Also called UGIR
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 group | Role | What they receive |
|---|---|---|
| Nutrition Support Product | Experimental | Participants were asked to take a nutrition support product twice per day for a period of 6 weeks. Receives: Other: Nutrition Support Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gastrointestinal Quality of Life Index (GIQLI) Score
Measured: 6 weeks
Secondary outcomes (3)
Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Score
Measured: 6 weeks
Change in Celiac Disease Questionnaire (CDQ) Score
Measured: 6 weeks
Change in Digestive Symptom Frequency Questionnaire (DSFQ) Score
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study startNov 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Metagenics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National University of Natural Medicine
- Responsible party
- Sponsor
- Investigators
- Nikhat Contractor, PhD, Study director, Metagenics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03011593
- Sponsor's protocol ID
- UGIR
- Status last verified
- Apr 2022
- First submitted
- 14 Dec 2016
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of UGIR on Quality of Life in Adults With Compromised Gut Function and Malabsorption
- ClinicalTrials.gov ID
- NCT03011593
- Acronym / sponsor ID
- UGIR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Metagenics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National University of Natural Medicine
- Study start
- Nov 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 5 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nutrition Support Product | Experimental | Other: Nutrition Support ProductParticipants were asked to take a nutrition support product twice per day for a period of 6 weeks. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body mass index 19 - 40 kg/m2
- Previous diagnosis of ulcerative colitis (UC), Crohn's disease, irritable bowel syndrome (IBS), or celiac disease
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition Support ProductAlso: UGIRNutrition 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 | Nutrition Support Product |
Primary outcome
Change in Gastrointestinal Quality of Life Index (GIQLI) Score
Time frame: 6 weeks
3 secondary outcomes
Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Score
Time frame: 6 weeks
Change in Celiac Disease Questionnaire (CDQ) Score
Time frame: 6 weeks
Change in Digestive Symptom Frequency Questionnaire (DSFQ) Score
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Background: PubMed 33799455Ryan 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Irritable Bowel Syndrome
Not yet recruiting
Nutritional Management of the Irritable Bowel Syndrome(IBS): The Role of the Mediterranean Diet (MD)
Irritable Bowel Syndrome
Not yet recruiting
The Mechanism Underlying the Analgesic Effect of the Music of IBS Pain
Abdominal Pain/ Discomfort, Irritable Bowel Syndrome
Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
Not yet recruiting
NEUROMODULATION WITH TRANSCUTANEOUS AURICULAR VAGUS NERVE STIMULATION IN ADULTS WITH IRRITABLE BOWEL SYNDROME: A RANDOMIZED, SINGLE-BLIND, SHAM-CONTROLLED CROSSOVER STUDY
Irritable Bowel Syndrome (IBS)
RecruitingObservational study
Relationship Between Interoception and Postural Control in Constipation-Predominant Irritable Bowel Syndrome
Constipation, Irritable Bowel Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikhat Contractor, PhD study director
Metagenics, Inc.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition Support Product in people with Irritable Bowel Syndrome and Crohn Disease, run by Metagenics, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gastrointestinal Quality of Life Index (GIQLI) Score (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03011593, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022; AzTrials last refreshed its copy on 31 Oct 2026.