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

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.

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome (IBS)
• Intervention / Treatment: Other: Fuco-N-Tetraose

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 Type: Interventional
• Enrollment (Actual): 317
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27516
      • University of North Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline and after 4, 8 and 12 weeks of intake

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	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	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	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)	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)	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)	Baseline and after 4, 8 and 12 weeks of intake

Collaborators and Investigators

• Sponsor: Glycom, Inc.
• Collaborators: University of North Carolina
• Investigators: Principal Investigator: Olafur Palsson, PsyD, Prof, UNC-Chapel Hill School of Medicine

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2018
• Primary Completion (Actual): March 20, 2019
• Study Completion (Actual): March 20, 2019

Study Registration Dates

• First Submitted: May 9, 2018
• First Submitted That Met QC Criteria: June 7, 2018
• First Posted (Actual): June 8, 2018

Study Record Updates

• Last Update Posted (Actual): April 25, 2019
• Last Update Submitted That Met QC Criteria: April 24, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: IBS-D; IBS-C; IBS-M; Human Milk Oligosaccharides
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Irritable Bowel Syndrome
• Other Study ID Numbers: GRIPS; CT-2017-01 (Other Identifier: IntegReview IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No