Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06068894 · ClinicalTrials.gov registry record · NA
Safety, Tolerability, and Biosignature of Humanized Prebiotics in Healthy Adults
A NA study of Intestinal Health, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT06068894 is a NA study of Intestinal Health that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 60 participants. The trial reports 1 study location across 1 state.
The verdict
NCT06068894, a NA study of Intestinal Health, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- OTHER Matching Placebo
- DIETARY_SUPPLEMENT "Humanized" galacto-oligosaccharides (hGOS)
- DIETARY_SUPPLEMENT Galacto-oligosaccharides (GOS)
Study Locations (1)
North Carolina
- UNC-Chapel Hill - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-06-13 |
| Est. Completion | 2025-03-26 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06068894
The ClinicalTrials.gov registry entry for NCT06068894 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Intestinal Health appearing as the primary indexed condition, and to 3 interventions - of which Matching Placebo is the first listed.
NCT06068894 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT06068894 about?
NCT06068894 is a clinical study titled "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 safe...
What is the current status of trial NCT06068894?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2024-06-13. Estimated completion is 2025-03-26.
What conditions does trial NCT06068894 study?
This clinical trial studies the following conditions: Intestinal Health.
What interventions are being tested in trial NCT06068894?
The interventions under investigation include: Matching Placebo (OTHER), "Humanized" galacto-oligosaccharides (hGOS) (DIETARY_SUPPLEMENT), Galacto-oligosaccharides (GOS) (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT06068894?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06068894 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.