Irritable Bowel Syndrome (IBS)GRIPSNCT03550742
Effect of HMOs as Nutritional Support for Normal Bowel Movements in IBS Patients
A study testing Fuco-N-Tetraose in people with Irritable Bowel Syndrome (IBS), run by Glycom, Inc. at 1 site in United States.
Trial summary
This is an open labeled, one-armed real-world study in IBS-patients. All participants will receive active treatment for 12 weeks. The primary objective of the study is to assess the effect of Human Milk Oligosaccharides (HMOs) on bowel function in adults with IBS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome (IBS)
- What is being tested?
- Fuco-N-Tetraose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 317 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2018to 20 Mar 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to give oral and written informed consent
- Age minimum 18 years at enrolment
- Current clinical diagnosis of IBS from a healthcare provider, and meeting Rome IV IBS diagnostic criteria
- Ability and willingness to understand and comply with the study procedures
- Ability to read, speak and understand English
- Free access to the internet via computer, tablet or smartphone to complete study surveys and also to allow for study team follow-up as needed.
Who cannot join
- Participation in a clinical intervention study one month prior to screening visit and throughout the study.
- Medically diagnosed with celiac disease, Crohn's disease, ulcerative colitis, diverticulitis, inflammatory bowel disease, or clostridium difficile infection by a doctor
- Pregnant or lactating or wish to become pregnant during the period of the study.
- Lack of suitability for participation in the study for any reason as judged by the site investigator or Principal Investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina
Chapel Hill, North Carolina, 27516
About this study
Official title: Real-World Perception of Tolerability and Bowel Function Effects of Fuco-N-Tetraose in IBS Patients
This is an open labeled, one-armed real-world study in IBS-patients. All participants will receive active treatment for 12 weeks.
The primary objective of the study is to assess the effect of Human Milk Oligosaccharides (HMOs) on bowel function in adults with IBS. Secondary objectives are to evaluate HMOs' tolerability, effect on participant reported satisfaction with bowel habits, interference with life in general, quality of life, somatic symptoms, and anxiety and depression in all patients and subgroups of patients.
Read the detailed description
In this trial, a total of 300 adults (at least 18 years of age) diagnosed with irritable bowel syndrome (IBS) in accordance with the Rome IV criteria will be included. Patients will be recruited from gastroenterologists and primary care clinics across the USA. The study product, Fuco-N-Tetraose, will be taken daily throughout the course of the trial. All data will be collected through 4 web based surveys, and the participants will complete those at baseline before the intervention starts, and after 4, 8 and 12 weeks of intake of the study product.
The primary outcome of the study will be assessed by the Patients' Global Impression of Change (PGIC) scale. Other questionnaires used in the study includes the IBS specific Gastrointestinal Symptom Rating Scale (GSRS-IBS), the IBS Quality of Life Scale (IBS-QoL), the Participant Health Questionnaire-4 (PHQ-4), the Participant Health Questionnaire-12 (PHQ-12), and the Bristol Stool Form Scale (BSFS). All outcomes will be evaluated in all patients and in sub-groups of patients. i.e. subtypes by predominant bowel habit (diarrhea-predominant, constipation-predominant, or altered/mixed pattern), and lactose intolerant patients.
- Conditions
- Irritable Bowel Syndrome (IBS)
- Being tested
- Fuco-N-Tetraose
- Keywords
- Human Milk Oligosaccharides, IBS-C, IBS-D, IBS-M
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fuco-N-TetraoseOther
Daily bolus of Fuco-N-Tetraose
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Daily administration of 5g of Fuco-N-Tetraose as a bolus for a period of 12 weeks. Receives: Other: Fuco-N-Tetraose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in bowel function
Change from baseline in bowel function assessed as the proportion of bowel movements with abnormal fecal consistency measured with the Bristol Stool Form Scale
Measured: Baseline and after 4, 8 and 12 weeks of intake
Secondary outcomes (8)
Change in patients' perception of body function
Change from baseline in patients' perception of body function measured by the Patients' Global Impression of Change (PGIC) scale.
Measured: Baseline and after 4, 8 and 12 weeks of intake
Evaluate tolerability of fuco-N-tetraose
Evaluate tolerability of fuco-N-tetraose using GSRS-IBS
Measured: Baseline and after 4, 8 and 12 weeks of intake
Evaluate tolerability of fuco-N-tetraose
Evaluate tolerability of fuco-N-tetraose using IBS-SSS
Measured: Baseline and after 4, 8 and 12 weeks of intake
Change in satisfaction with bowel habits
Change from baseline in satisfaction with bowel habits measured with IBS-SSS
Measured: Baseline and after 4, 8 and 12 weeks of intake
Change in IBS' interference in life in general
Change from baseline in IBS' interference in life in general measured with IBS-SSS
Measured: Baseline and after 4, 8 and 12 weeks of intake
Change in quality of life
Change from baseline in quality of life measured with the IBS Quality of Life Scale (IBS-QoL)
Measured: Baseline and after 4, 8 and 12 weeks of intake
Change on somatic symptoms
Change from baseline on somatic symptoms measured with the Participant Health Questionnaire-12 (PHQ-12)
Measured: Baseline and after 4, 8 and 12 weeks of intake
Change in anxiety and depression
Change from baseline in anxiety and depression measured with the Participant Health Questionnaire-4 (PHQ-4)
Measured: Baseline and after 4, 8 and 12 weeks of intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start14 May 2018
- Primary completion20 Mar 2019
- Study completion20 Mar 2019
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 Syndrome (IBS)Studies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glycom, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of North Carolina
- Responsible party
- Sponsor
- Investigators
- Olafur Palsson, PsyD, Prof, Principal investigator, UNC-Chapel Hill School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03550742
- Sponsor's protocol ID
- GRIPS
- Other IDs
- CT-2017-01
- Acronym
- GRIPS
- Status last verified
- Apr 2019
- First submitted
- 9 May 2018
- Last updated
- 25 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Palsson OS, Peery A, Seitzberg D, Amundsen ID, McConnell B, Simren M. Human Milk Oligosaccharides Support Normal Bowel Function and Improve Symptoms of Irritable Bowel Syndrome: A Multicenter, Open-Label Trial. Clin Transl Gastroenterol. 2020 Dec;11(12):e00276. doi: 10.14309/ctg.0000000000000276.
PubMed 33512807
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Perception of Tolerability and Bowel Function Effects of Fuco-N-Tetraose in IBS Patients
- ClinicalTrials.gov ID
- NCT03550742
- Acronym / sponsor ID
- GRIPS / GRIPS
- Conditions
- Irritable Bowel Syndrome (IBS)
- Keywords
- Human Milk Oligosaccharides, IBS-C, IBS-D, IBS-M
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- Glycom, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of North Carolina
- Study start
- 14 May 2018 (actual)
- Primary completion
- 20 Mar 2019 (actual)
- Study completion
- 20 Mar 2019 (actual)
- First posted
- 8 Jun 2018 (actual)
- 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 is an open labeled, one-armed real-world study in IBS-patients. All participants will receive active treatment for 12 weeks.
The primary objective of the study is to assess the effect of Human Milk Oligosaccharides (HMOs) on bowel function in adults with IBS. Secondary objectives are to evaluate HMOs' tolerability, effect on participant reported satisfaction with bowel habits, interference with life in general, quality of life, somatic symptoms, and anxiety and depression in all patients and subgroups of patients.
Detailed description
In this trial, a total of 300 adults (at least 18 years of age) diagnosed with irritable bowel syndrome (IBS) in accordance with the Rome IV criteria will be included. Patients will be recruited from gastroenterologists and primary care clinics across the USA. The study product, Fuco-N-Tetraose, will be taken daily throughout the course of the trial. All data will be collected through 4 web based surveys, and the participants will complete those at baseline before the intervention starts, and after 4, 8 and 12 weeks of intake of the study product.
The primary outcome of the study will be assessed by the Patients' Global Impression of Change (PGIC) scale. Other questionnaires used in the study includes the IBS specific Gastrointestinal Symptom Rating Scale (GSRS-IBS), the IBS Quality of Life Scale (IBS-QoL), the Participant Health Questionnaire-4 (PHQ-4), the Participant Health Questionnaire-12 (PHQ-12), and the Bristol Stool Form Scale (BSFS). All outcomes will be evaluated in all patients and in sub-groups of patients. i.e. subtypes by predominant bowel habit (diarrhea-predominant, constipation-predominant, or altered/mixed pattern), and lactose intolerant patients.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Fuco-N-TetraoseDaily administration of 5g of Fuco-N-Tetraose as a bolus for a period of 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ability to give oral and written informed consent
- Age minimum 18 years at enrolment
- Current clinical diagnosis of IBS from a healthcare provider, and meeting Rome IV IBS diagnostic criteria
- Ability and willingness to understand and comply with the study procedures
- Ability to read, speak and understand English
Key exclusion criteria (4 listed)
- Participation in a clinical intervention study one month prior to screening visit and throughout the study.
- Medically diagnosed with celiac disease, Crohn's disease, ulcerative colitis, diverticulitis, inflammatory bowel disease, or clostridium difficile infection by a doctor
- Pregnant or lactating or wish to become pregnant during the period of the study.
- Lack of suitability for participation in the study for any reason as judged by the site investigator or Principal Investigator.
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 |
|---|---|---|
| Fuco-N-TetraoseDaily bolus of Fuco-N-Tetraose | Other | Intervention |
Primary outcome
Change from baseline in bowel function
Time frame: Baseline and after 4, 8 and 12 weeks of intake
Change from baseline in bowel function assessed as the proportion of bowel movements with abnormal fecal consistency measured with the Bristol Stool Form Scale
8 secondary outcomes
Change in patients' perception of body function
Time frame: Baseline and after 4, 8 and 12 weeks of intake
Evaluate tolerability of fuco-N-tetraose
Time frame: Baseline and after 4, 8 and 12 weeks of intake
Evaluate tolerability of fuco-N-tetraose
Time frame: Baseline and after 4, 8 and 12 weeks of intake
Change in satisfaction with bowel habits
Time frame: Baseline and after 4, 8 and 12 weeks of intake
Change in IBS' interference in life in general
Time frame: Baseline and after 4, 8 and 12 weeks of intake
Change in quality of life
Time frame: Baseline and after 4, 8 and 12 weeks of intake
Change on somatic symptoms
Time frame: Baseline and after 4, 8 and 12 weeks of intake
Change in anxiety and depression
Time frame: Baseline and after 4, 8 and 12 weeks of intake
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 25 Apr 2019.
- Derived from this study: PubMed 33512807Palsson OS, Peery A, Seitzberg D, Amundsen ID, McConnell B, Simren M. Human Milk Oligosaccharides Support Normal Bowel Function and Improve Symptoms of Irritable Bowel Syndrome: A Multicenter, Open-Label Trial. Clin Transl Gastroenterol. 2020 Dec;11(12):e00276. doi: 10.14309/ctg.0000000000000276.
- Individual participant dataSharing planned: No
Related trials for Irritable Bowel Syndrome (IBS)
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
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.
Olafur Palsson, PsyD, Prof principal investigator
UNC-Chapel Hill School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fuco-N-Tetraose in people with Irritable Bowel Syndrome (IBS), run by Glycom, Inc. at 1 site in United States.
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 6 inclusion and 4 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 25 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 from baseline in bowel function (time frame: Baseline and after 4, 8 and 12 weeks of intake). 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 NCT03550742, 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 25 Apr 2019.