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Effect of HMOs as Nutritional Support for Normal Bowel Movements in IBS Patients (GRIPS)

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ClinicalTrials.gov Identifier: NCT03550742
Recruitment Status : Completed
First Posted : June 8, 2018
Last Update Posted : April 25, 2019
Sponsor:
Collaborator:
University of North Carolina
Information provided by (Responsible Party):
Glycom A/S ( Glycom, Inc. )

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome (IBS) Other: Fuco-N-Tetraose Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 317 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Real-World Perception of Tolerability and Bowel Function Effects of Fuco-N-Tetraose in IBS Patients
Actual Study Start Date : May 14, 2018
Actual Primary Completion Date : March 20, 2019
Actual Study Completion Date : March 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement Flu

Arm Intervention/treatment
Experimental: Intervention
Daily administration of 5g of Fuco-N-Tetraose as a bolus for a period of 12 weeks.
Other: Fuco-N-Tetraose
Daily bolus of Fuco-N-Tetraose




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change in patients' perception of body function [ Time Frame: Baseline and after 4, 8 and 12 weeks of intake ]
    Change from baseline in patients' perception of body function measured by the Patients' Global Impression of Change (PGIC) scale.

  2. Evaluate tolerability of fuco-N-tetraose [ Time Frame: Baseline and after 4, 8 and 12 weeks of intake ]
    Evaluate tolerability of fuco-N-tetraose using GSRS-IBS

  3. Evaluate tolerability of fuco-N-tetraose [ Time Frame: Baseline and after 4, 8 and 12 weeks of intake ]
    Evaluate tolerability of fuco-N-tetraose using IBS-SSS

  4. Change in satisfaction with bowel habits [ Time Frame: Baseline and after 4, 8 and 12 weeks of intake ]
    Change from baseline in satisfaction with bowel habits measured with IBS-SSS

  5. Change in IBS' interference in life in general [ Time Frame: Baseline and after 4, 8 and 12 weeks of intake ]
    Change from baseline in IBS' interference in life in general measured with IBS-SSS

  6. Change in quality of life [ Time Frame: Baseline and after 4, 8 and 12 weeks of intake ]
    Change from baseline in quality of life measured with the IBS Quality of Life Scale (IBS-QoL)

  7. Change on somatic symptoms [ Time Frame: Baseline and after 4, 8 and 12 weeks of intake ]
    Change from baseline on somatic symptoms measured with the Participant Health Questionnaire-12 (PHQ-12)

  8. Change in anxiety and depression [ Time Frame: Baseline and after 4, 8 and 12 weeks of intake ]
    Change from baseline in anxiety and depression measured with the Participant Health Questionnaire-4 (PHQ-4)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Ability to give oral and written informed consent
  2. Age minimum 18 years at enrolment
  3. Current clinical diagnosis of IBS from a healthcare provider, and meeting Rome IV IBS diagnostic criteria
  4. Ability and willingness to understand and comply with the study procedures
  5. Ability to read, speak and understand English
  6. 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.

Exclusion Criteria:

  1. Participation in a clinical intervention study one month prior to screening visit and throughout the study.
  2. Medically diagnosed with celiac disease, Crohn's disease, ulcerative colitis, diverticulitis, inflammatory bowel disease, or clostridium difficile infection by a doctor
  3. Pregnant or lactating or wish to become pregnant during the period of the study.
  4. Lack of suitability for participation in the study for any reason as judged by the site investigator or Principal Investigator.

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): NCT03550742


Locations
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United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27516
Sponsors and Collaborators
Glycom, Inc.
University of North Carolina
Investigators
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Principal Investigator: Olafur Palsson, PsyD, Prof UNC-Chapel Hill School of Medicine

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Responsible Party: Glycom, Inc.
ClinicalTrials.gov Identifier: NCT03550742     History of Changes
Other Study ID Numbers: GRIPS
CT-2017-01 ( Other Identifier: IntegReview IRB )
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Glycom A/S ( Glycom, Inc. ):
Human Milk Oligosaccharides
IBS-C
IBS-D
IBS-M

Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases