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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: Completed NA study of Intestinal Health, sponsored by University of North Carolina, Chapel Hill.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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 i
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 |
What the finished NCT06068894 record still lists
NCT06068894 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
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 a single indexed study location in 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
How this trial's enrollment target compares
Where NCT06068894's enrollment target sits among peer trials
60 1164th of 2000 higher than 745 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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