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

Completed · Not applicable

Conditions studied: Irritable Bowel Syndrome (IBS)

In brief

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.

Key facts

Study ID

NCT03550742

Run by

Glycom, Inc.

People needed

317

Starts

2018-05-14

Expected to finish

2019-03-20

Last updated by the study team

2019-04-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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