NCT03550742

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 317 (actual)
• Sponsor: Glycom, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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)

Interventions

Type	Name	Description
OTHER	Fuco-N-Tetraose	Daily bolus of Fuco-N-Tetraose

Timeline

• Start date: 2018-05-14
• Primary completion: 2019-03-20
• Completion: 2019-03-20
• First posted: 2018-06-08
• Last updated: 2019-04-25

Locations

1 site across 1 country: United States