Clinical trial NCT06068894: Safety, Tolerability, and Biosignature of Humanized Prebiotics in Healthy Adults
Official title: Safety, Tolerability, and Biosignature of Humanized Prebiotics in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intestinal Health
Keywords: Prebiotics
Galactooligosaccharides
Lactosamine
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: North Carolina Translational and Clinical Sciences Institute
First posted: 2023-10-05
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 arms: GOS, hGOS, or placebo, with 16 participants per arm.
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Mean GSSC Scores
timeFrame: Baseline, Week 4
Secondary outcomes:
measure: Difference in Percent Abundance of Beneficial Bacteria
timeFrame: Baseline, Week 4
measure: Change in Interleukin-1α Concentration
timeFrame: Baseline, Week 4
measure: Change in Interleukin-1ß Concentration
timeFrame: Baseline, Week 4
measure: Change in Interleukin-2 Concentration
timeFrame: Baseline, Week 4
measure: Change in Interleukin-6 Concentration
timeFrame: Baseline, Week 4
measure: Change in Interleukin-8 Concentration
timeFrame: Baseline, Week 4
measure: Change in Interleukin-12 Concentration
timeFrame: Baseline, Week 4
measure: Change in Tumor Necrosis Factor Alpha (TNF-α) Concentration
timeFrame: Baseline, Week 4
measure: Change in Interferon gamma (IFNγ) Concentration
timeFrame: Baseline, Week 4
measure: Change in C-Reactive Protein Concentration
timeFrame: Baseline, Week 4
measure: Change in Zonulin Concentration
timeFrame: Baseline, Week 4
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC-Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Sylvia Becker-Dreps, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: