NCT06068894

Safety, Tolerability, and Biosignature of Humanized Prebiotics in Healthy Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study aims to establish the safety of a 15 g/day dose of pure prebiotics ß(1-4) galacto-oligosaccharides (GOS) and GOS enriched with N-Acetyl-D-lactosamine, a building block of gut glycoproteins and human milk oligosaccharides (LAcNac, humanized GOS, hGOS) in healthy adult individuals. The safety and tolerability of the dose and the biological signature of GOS and hGOS in healthy adults will be established through a pilot clinical trial to assess GOS and hGOS effects vs placebo on (i) gastrointestinal adverse effects as measured by the Gastrointestinal Symptom and Severity Checklist (GSSC), (ii) increased abundance of beneficial gut bacteria and restoration of the gut microbiome saccharolytic potential, (iii) modulation of biomarkers of inflammation and (iv) evaluation of intestinal barrier function.

Conditions

• Intestinal Health

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	"Humanized" galacto-oligosaccharides (hGOS)	10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage
DIETARY_SUPPLEMENT	Galacto-oligosaccharides (GOS)	10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage.
OTHER	Matching Placebo	10-15 g/day powdered corn syrup comprised of fructose, glucose, and an inert cellulose material that matches the consistency, color sweetness, and taste of the prebiotics, that can be added to any non-alcoholic beverage.

Timeline

• Start date: 2024-06-13
• Primary completion: 2025-03-26
• Completion: 2025-03-26
• First posted: 2023-10-05
• Last updated: 2026-02-05
• Results posted: 2026-02-05

Locations

1 site across 1 country: United States