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

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 Overview

• Status: Completed
• Conditions: Intestinal Health
• Intervention / Treatment: Dietary supplement: "Humanized" galacto-oligosaccharides (hGOS); Dietary supplement: Galacto-oligosaccharides (GOS); Other: Matching Placebo

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC-Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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; Other Names: hGOS
Experimental: 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.	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 Names: GOS
Placebo Comparator: 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.	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.; Other Names: Sugar powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Percent Change in Relative Abundance of Beneficial Bacteria	The difference in relative abundance of beneficial bacteria of interest include Bifidobacterium and Akkermansia (pre and post intervention) as measured by whole genome sequencing of stool.	Between week 0 (Baseline) and week 4
Interleukin-1α Concentration	Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.	Between week 0 (Baseline) and week 4
Interleukin-1ß Concentration	Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.	Between week 0 (Baseline) and week 4
Interleukin-6 Concentration	Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.	Between week 0 (Baseline) and week 4
Interleukin-8 Concentration	Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.	Between week 0 (Baseline) and week 4
Interleukin-12 Concentration	Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.	Between week 0 (Baseline) and week 4
Interleukin-17 Concentration	Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.	Between week 0 (Baseline) and week 4
Interleukin-18 Concentration	Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.	Between week 0 (Baseline) and week 4
Tumor Necrosis Factor Alpha (TNF-α) Concentration	Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.	Between week 0 (Baseline) and week 4
Interferon Gamma (IFNγ) Concentration	Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.	Between week 0 (Baseline) and week 4
Change in C-Reactive Protein Concentration	Modulation of inflammatory biomarker as measured in serum by commercial enzyme-linked immunosorbent assay (ELISA) kit reported in mg/L.	Between week 0 (Baseline) and week 4
Change in Zonulin Concentration	Used to assess modulation in intestinal barrier function in blood and reported in ng/mL.	Between week 0 (Baseline) and week 4

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: North Carolina Translational and Clinical Sciences Institute
• Investigators: Principal Investigator: Sylvia Becker-Dreps, MD, MPH, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2024
• Primary Completion (Actual): March 26, 2025
• Study Completion (Actual): March 26, 2025

Study Registration Dates

• First Submitted: September 28, 2023
• First Submitted That Met QC Criteria: September 28, 2023
• First Posted (Actual): October 5, 2023

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Prebiotics; Galactooligosaccharides; Lactosamine
• Other Study ID Numbers: 21-2453

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
• IPD Sharing Time Frame: beginning 9 and continuing for 36 months following publication
• IPD Sharing Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No