MedTrace Logo

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

NCT06068894 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-02-05

Study results available
· View outcomes & findings →

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

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.

Sponsors & Collaborators

  • North Carolina Translational and Clinical Sciences Institute

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Sylvia Becker-Dreps, MD, MPH · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-13
Primary Completion
2025-03-26
Completion
2025-03-26

Countries

  • United States

Study Locations

More Related Trials

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 NCT06068894 on ClinicalTrials.gov