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

Intestinal Health Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06068894
• Other study ID #: 21-2453
• Status: Recruiting
• Phase: N/A
• Start date: June 13, 2024
• Est. completion date: November 2025

Study information

• Verified date: June 2024
• Source: University of North Carolina, Chapel Hill
• Contact: Sylvia Becker-Dreps, MD, MPH
• Phone: 919-943-7445
• Email: sbd[@]unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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 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

Related Conditions & MeSH terms

• Intestinal Health

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	UNC-Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	North Carolina Translational and Clinical Sciences Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean GSSC Scores	Safe and tolerable dose of hGOS and GOS in healthy adult individuals will be measured using the Gastrointestinal Symptom and Severity Checklist (GSSC) score. The GSSC is a 38-item interviewer-administered structured questionnaire designed to assess symptoms of gastrointestinal symptoms with scores ranging from 0 to 114, with higher scores indicating more gastrointestinal symptoms.	Baseline, Week 4
Secondary	Difference in Percent Abundance of Beneficial Bacteria	The abundance of beneficial bacteria of interest include Bifidobacterium and Akkermansia as measured by whole genome sequencing of stool.	Baseline, Week 4
Secondary	Change in Interleukin-1a Concentration	Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.	Baseline, Week 4
Secondary	Change in Interleukin-1ß Concentration	Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.	Baseline, Week 4
Secondary	Change in Interleukin-2 Concentration	Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.	Baseline, Week 4
Secondary	Change in Interleukin-6 Concentration	Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.	Baseline, Week 4
Secondary	Change in Interleukin-8 Concentration	Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.	Baseline, Week 4
Secondary	Change in Interleukin-12 Concentration	Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.	Baseline, Week 4
Secondary	Change in Tumor Necrosis Factor Alpha (TNF-a) Concentration	Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.	Baseline, Week 4
Secondary	Change in Interferon gamma (IFN?) Concentration	Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.	Baseline, Week 4
Secondary	Change in C-Reactive Protein Concentration	Modulation of inflammatory biomarker as measured in blood by commercial enzyme-linked immunosorbent assay (ELISA) kit reported in mg/L.	Baseline, Week 4
Secondary	Change in Zonulin Concentration	Used to assess modulation in intestinal barrier function in blood and reported in ng/mL.	Baseline, Week 4