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

NCT ID: NCT06068894

Last Updated: 2026-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-13
• Study Completion Date: 2025-03-26

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

lactosamine-enriched "humanized" galacto-oligosaccharides (hGOS)

The treatment will consist of 10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks.

Group Type: EXPERIMENTAL

"Humanized" galacto-oligosaccharides (hGOS)

Intervention Type: DIETARY_SUPPLEMENT

10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage

galacto-oligosaccharides (GOS)

The treatment will consist of 10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks.

Group Type: EXPERIMENTAL

Galacto-oligosaccharides (GOS)

Intervention Type: DIETARY_SUPPLEMENT

10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage.

Placebo

The placebo comparator treatment will consist of 10-15 g/day placebo powder, that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks to mirror the treatment arms. The study will end after the second time-point sample collection at 4 weeks.

Group Type: PLACEBO_COMPARATOR

Matching Placebo

Intervention Type: OTHER

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.

Interventions

"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

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: OTHER

Other Intervention Names

hGOS; GOS; Sugar powder

Eligibility Criteria

Inclusion Criteria

• All participants will be nonsmokers and well-nourished according to standard anthropometric criteria with BMI between 18.5 and 32.
• Individuals must be able to give informed consent.
• Subjects willing and able to:

• consume prebiotics or placebo preparations for a period of 4 weeks.
• Record daily food consumption using the Centers for Disease Control and Prevention (CDC) My Food Diary questionnaire.
• provide stool and blood (via venipuncture) samples.
• Enrollment will not be restricted based on race, ethnicity, or gender. The subject population will reflect the population providing a broad selection of individuals to allow enrollment of subjects from all races, ethnicities, and genders, as represented in North Carolina state.

Exclusion Criteria

• Less than 18 years of age or older than 55 years of age
• Pregnant or breastfeeding

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

North Carolina Translational and Clinical Sciences Institute

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sylvia Becker-Dreps, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

UNC-Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

21-2453

Identifier Type: -

Identifier Source: org_study_id