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Completed

NCT Number: NCT03550742

Effect of HMOs as Nutritional Support for Normal Bowel Movements 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.

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Key information

Conditions

Irritable Bowel Syndrome (IBS) Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina

Chapel Hill, North Carolina, 27516, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Fuco-N-Tetraose

Other

Daily bolus of Fuco-N-Tetraose

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Glycom, Inc.

Industry

Collaborators

  • University of North Carolina

Registry information

Official study title

Real-World Perception of Tolerability and Bowel Function Effects of Fuco-N-Tetraose in IBS Patients

Acronym: GRIPS

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 8, 2018
Registry last updated
Apr 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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