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

RECRUITING

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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

🗓️ Study Start (Actual) 13 June 2024

🗓️ Primary Completion (Estimated) November 2025

✅ Study Completion (Estimated) November 2025

👥 Enrollment (Estimated) 48

🔬 Study Type INTERVENTIONAL

📊 Phase NA

Locations:

📍 Chapel Hill, North Carolina, United States

📋 Eligibility Criteria

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 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

Ages Eligible for Study: 18 Years to 55 Years (ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 28 September 2023
First Submitted that Met QC Criteria 28 September 2023
First Posted 5 October 2023

Study Record Updates

Last Update Submitted that Met QC Criteria 17 June 2024
Last Update Posted 18 June 2024
Last Verified June 2024