At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety, Tolerability, and Biosignature of Humanized Prebiotics in Healthy Adults
In Brief
A clinical study evaluating "Humanized" galacto-oligosaccharides (hGOS), Galacto-oligosaccharides (GOS), and 1 other intervention for Intestinal Health. Completed, enrolled 60 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage
10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage.
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.