Skip to main content
OpenTrials
Completed

NCT Number: NCT06068894

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Intestinal Health

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNC-Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

"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

Other names: 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.

Other names: 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.

Other names: Sugar powder

Primary outcomes

  1. Mean Composite PROMIS Maximum Scores

    Time frame: Between week 0 (Baseline) and week 4

    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.

Secondary outcomes

  1. Mean Percent Change in Relative Abundance of Beneficial Bacteria

    Time frame: Between week 0 (Baseline) and week 4

    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.

  2. Interleukin-1α Concentration

    Time frame: Between week 0 (Baseline) and week 4

    Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.

  3. Interleukin-1ß Concentration

    Time frame: Between week 0 (Baseline) and week 4

    Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.

  4. Interleukin-6 Concentration

    Time frame: Between week 0 (Baseline) and week 4

    Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.

  5. Interleukin-8 Concentration

    Time frame: Between week 0 (Baseline) and week 4

    Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.

  6. Interleukin-12 Concentration

    Time frame: Between week 0 (Baseline) and week 4

    Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.

  7. Interleukin-17 Concentration

    Time frame: Between week 0 (Baseline) and week 4

    Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.

  8. Interleukin-18 Concentration

    Time frame: Between week 0 (Baseline) and week 4

    Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.

  9. Tumor Necrosis Factor Alpha (TNF-α) Concentration

    Time frame: Between week 0 (Baseline) and week 4

    Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.

  10. Interferon Gamma (IFNγ) Concentration

    Time frame: Between week 0 (Baseline) and week 4

    Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.

  11. Change in C-Reactive Protein Concentration

    Time frame: Between week 0 (Baseline) and week 4

    Modulation of inflammatory biomarker as measured in serum by commercial enzyme-linked immunosorbent assay (ELISA) kit reported in mg/L.

  12. Change in Zonulin Concentration

    Time frame: Between week 0 (Baseline) and week 4

    Used to assess modulation in intestinal barrier function in blood and reported in ng/mL.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • North Carolina Translational and Clinical Sciences Institute

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 5, 2023
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.