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

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

Study Description

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 317 participants
• Allocation: N/A
• 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

Arms and Interventions

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

Outcome Measures

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)

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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

• Principal Investigator: Olafur Palsson, PsyD, Prof; UNC-Chapel Hill School of Medicine

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Palsson OS, Peery A, Seitzberg D, Amundsen ID, McConnell B, Simrén 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.

• Responsible Party: Glycom, Inc.
• ClinicalTrials.gov Identifier: NCT03550742
• Other Study ID Numbers: GRIPS; CT-2017-01 ( Other Identifier: IntegReview IRB )
• First Posted: June 8, 2018
• Last Update Posted: April 25, 2019
• Last Verified: April 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Irritable Bowel Syndrome; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases