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

NCT03550742 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 317

Last updated 2019-04-25

No results posted yet for this study

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.

Conditions

  • Irritable Bowel Syndrome (IBS)

Interventions

OTHER

Fuco-N-Tetraose

Daily bolus of Fuco-N-Tetraose

Sponsors & Collaborators

  • University of North Carolina

    collaborator OTHER

  • Glycom, Inc.

    lead INDUSTRY

Principal Investigators

  • Olafur Palsson, PsyD, Prof · UNC-Chapel Hill School of Medicine

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-14
Primary Completion
2019-03-20
Completion
2019-03-20

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03550742 on ClinicalTrials.gov