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

NCT06068894 | Completed Results

• 1 other identifier: 21-2453
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Prebiotics; Galactooligosaccharides; Lactosamine

Outcome Measures

Primary Outcomes (1)

• Mean Composite PROMIS Maximum Scores

  The overall Patient-Reported Outcomes Measurement Information System (PROMIS) score symptom (composite) was calculated as follows: Individual items from the GI questionnaire were grouped into seven symptom domains: abdominal pain, bloating, abdominal distension, flatulence, constipation, diarrhea, and nausea. Each item was rated on a 0-4 scale (0 = "never," 4 = "always"). For each participant at each visit (week 0 and week 4), a domain-specific symptom severity score was defined as the maximum item score within that domain (range 0-4). Using the seven domain severity scores, a composite PROMIS maximum GI measure was calculated for each visit. Composite PROMIS maximum was defined as the maximum severity score cumulatively across all seven domains, representing the participant's worst GI symptoms at that time point. The range of the composite PROMIS maximum score is 0-28 with lower scores representing lowest GI symptoms.

  Between week 0 (Baseline) and week 4

Secondary Outcomes (12)

• Mean Percent Change in Relative Abundance of Beneficial Bacteria

  Between week 0 (Baseline) and week 4

• Interleukin-1α Concentration

  Between week 0 (Baseline) and week 4

• Interleukin-1ß Concentration

  Between week 0 (Baseline) and week 4

• Interleukin-6 Concentration

  Between week 0 (Baseline) and week 4

• Interleukin-8 Concentration

  Between week 0 (Baseline) and week 4

Study Arms (3)

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

EXPERIMENTAL

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.

Dietary Supplement: "Humanized" galacto-oligosaccharides (hGOS)

galacto-oligosaccharides (GOS)

EXPERIMENTAL

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.

Dietary Supplement: Galacto-oligosaccharides (GOS)

Placebo

PLACEBO COMPARATOR

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.

Other: Matching Placebo

Interventions

"Humanized" galacto-oligosaccharides (hGOS) 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

Also known as: hGOS

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

Galacto-oligosaccharides (GOS) 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.

Also known as: GOS

galacto-oligosaccharides (GOS)

Matching Placebo 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.

Also known as: Sugar powder

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• North Carolina Translational and Clinical Sciences Institute: collaborator
• University of North Carolina, Chapel Hill: lead

Study Sites (1)

UNC-Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Results Point of Contact

• Title: Sylvia Becker-Dreps, MD, MPH
• Organization: University of North Carolina at Chapel Hill

sbd@email.unc.edu

984-974-4662

Study Officials

• Sylvia Becker-Dreps, MD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 3 arms: GOS, hGOS, or placebo, with 16 participants per arm.

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 5, 2023
• Study Start: June 13, 2024
• Primary Completion: March 26, 2025
• Study Completion: March 26, 2025
• Last Updated: February 5, 2026
• Results First Posted: February 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: beginning 9 and continuing for 36 months following publication
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)