NCT05205785

Human Milk Oligosaccharides (HMOs) for Irritable Bowel Syndrome (IBS)

Supporting Healthy Gastrointestinal Function With Human Milk Oligosaccharides (HMOs) in Individuals With Irritable Bowel Syndrome (IBS)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: dsm-firmenich Switzerland AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess the effects of a Human Milk Oligosaccharide mix given once daily for 12 weeks on stool consistency and abdominal pain compared to placebo in individuals with Irritable Bowel Syndrome (IBS).

Detailed description

HMO mix has been shown to provide therapeutic benefits to individuals with IBS of all subtypes (Palsson et al., 2019). DSM is planning this trial in order to investigate if clinically relevant improvements in bowel movements and IBS symptoms can be obtained through the use of the HMO mix in individuals with moderate to severe IBS and abdominal pain. Eligible participants will have a diagnosis of Irritable Bowel Syndrome (IBS). Participants will be assessed for eligibility at the screening visit, must meet all the inclusion criteria, and none of the exclusion criteria. In this trial, participants will be randomized to one of two intervention groups (a Human Milk Oligosaccharide mix or placebo) and receive intervention for at least 12 weeks.

Conditions

• Irritable Bowel Syndrome
• IBS - Irritable Bowel Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Human Milk Oligosaccharide Mix	Subjects takes 5.5 g of powder mixed in water once a day for 12 weeks.
OTHER	Placebo	The placebo to be used in this trial is 5.5 g of powdered dextrose powder in a single-serve stick pack. The participants will be instructed to mix the product in a 4-6 oz glass of water and consume in the morning once a day for 12 weeks.

Timeline

• Start date: 2023-03-22
• Primary completion: 2024-03-05
• Completion: 2024-06-24
• First posted: 2022-01-25
• Last updated: 2024-08-07

Locations

1 site across 1 country: Ireland