Intestinal HealthNCT06068894
Safety, Tolerability, and Biosignature of Humanized Prebiotics in Healthy Adults
A study testing "Humanized" galacto-oligosaccharides (hGOS) and Galacto-oligosaccharides (GOS) in people with Intestinal Health, run by University of North Carolina, Chapel Hill at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Intestinal Health
- What is being tested?
- "Humanized" galacto-oligosaccharides (hGOS) and Galacto-oligosaccharides (GOS)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2024to 26 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Less than 18 years of age or older than 55 years of age
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- "Humanized" galacto-oligosaccharides (hGOS), Galacto-oligosaccharides (GOS), Matching Placebo
- Keywords
- Prebiotics, Galactooligosaccharides, Lactosamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Humanized" galacto-oligosaccharides (hGOS)Dietary supplement
Also called 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)Dietary supplement
Also called 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.
Matching PlaceboOther
Also called Sugar powder
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.
| Study group | Role | What they receive |
|---|---|---|
| lactosamine-enriched "humanized" galacto-oligosaccharides (hGOS) | Experimental | The treatment will consist of 10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks. Receives: Dietary Supplement: "Humanized" galacto-oligosaccharides (hGOS) |
| galacto-oligosaccharides (GOS) | Experimental | The treatment will consist of 10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks. Receives: Dietary Supplement: Galacto-oligosaccharides (GOS) |
| Placebo | Placebo comparator | The placebo comparator treatment will consist of 10-15 g/day placebo powder, that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks to mirror the treatment arms. The study will end after the second time-point sample collection at 4 weeks. Receives: Other: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Composite PROMIS Maximum Scores
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 item score within that domain (range 0-4). Using the seven domain severity scores, a composite PROMIS maximum GI measure was calculated for each visit. Composite PROMIS maximum was defined as the maximum severity score cumulatively across all seven domains, representing the participant's worst GI symptoms at that time point. The range of the composite PROMIS maximum score is 0-28 with lower scores representing lowest GI symptoms.
Measured: Between week 0 (Baseline) and week 4
Secondary outcomes (12)
Mean Percent Change in Relative Abundance of Beneficial Bacteria
The difference in relative abundance of beneficial bacteria of interest include Bifidobacterium and Akkermansia (pre and post intervention) as measured by whole genome sequencing of stool.
Measured: Between week 0 (Baseline) and week 4
Interleukin-1α Concentration
Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.
Measured: Between week 0 (Baseline) and week 4
Interleukin-1ß Concentration
Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.
Measured: Between week 0 (Baseline) and week 4
Interleukin-6 Concentration
Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.
Measured: Between week 0 (Baseline) and week 4
Interleukin-8 Concentration
Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.
Measured: Between week 0 (Baseline) and week 4
Interleukin-12 Concentration
Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.
Measured: Between week 0 (Baseline) and week 4
Interleukin-17 Concentration
Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.
Measured: Between week 0 (Baseline) and week 4
Interleukin-18 Concentration
Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.
Measured: Between week 0 (Baseline) and week 4
Tumor Necrosis Factor Alpha (TNF-α) Concentration
Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.
Measured: Between week 0 (Baseline) and week 4
Interferon Gamma (IFNγ) Concentration
Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.
Measured: Between week 0 (Baseline) and week 4
Change in C-Reactive Protein Concentration
Modulation of inflammatory biomarker as measured in serum by commercial enzyme-linked immunosorbent assay (ELISA) kit reported in mg/L.
Measured: Between week 0 (Baseline) and week 4
Change in Zonulin Concentration
Used to assess modulation in intestinal barrier function in blood and reported in ng/mL.
Measured: Between week 0 (Baseline) and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start13 Jun 2024
- Primary completion26 Mar 2025
- Study completion26 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intestinal HealthStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 arms: GOS, hGOS, or placebo, with 16 participants per arm.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute
- Responsible party
- Sponsor
- Investigators
- Sylvia Becker-Dreps, MD, MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06068894
- Sponsor's protocol ID
- 21-2453
- Status last verified
- Dec 2025
- First submitted
- 28 Sep 2023
- Last updated
- 5 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, and Biosignature of Humanized Prebiotics in Healthy Adults
- ClinicalTrials.gov ID
- NCT06068894
- Acronym / sponsor ID
- 21-2453
- Conditions
- Intestinal Health
- Keywords
- Prebiotics, Galactooligosaccharides, Lactosamine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute
- Study start
- 13 Jun 2024 (actual)
- Primary completion
- 26 Mar 2025 (actual)
- Study completion
- 26 Mar 2025 (actual)
- First posted
- 5 Oct 2023 (actual)
- Results
- Posted 5 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 3 arms: GOS, hGOS, or placebo, with 16 participants per arm.
| Arm | Type | Receives |
|---|---|---|
| lactosamine-enriched "humanized" galacto-oligosaccharides (hGOS) | Experimental | Dietary Supplement: "Humanized" galacto-oligosaccharides (hGOS)The treatment will consist of 10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks. |
| galacto-oligosaccharides (GOS) | Experimental | Dietary Supplement: Galacto-oligosaccharides (GOS)The treatment will consist of 10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks. |
| Placebo | Placebo comparator | Other: Matching PlaceboThe placebo comparator treatment will consist of 10-15 g/day placebo powder, that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks to mirror the treatment arms. The study will end after the second time-point sample collection at 4 weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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:
- 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.
Key exclusion criteria (2 listed)
- Less than 18 years of age or older than 55 years of age
- Pregnant or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Humanized" galacto-oligosaccharides (hGOS)Also: hGOS10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage | Dietary supplement | lactosamine-enriched "humanized" galacto-oligosaccharides (hGOS) |
| Galacto-oligosaccharides (GOS)Also: GOS10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. | Dietary supplement | galacto-oligosaccharides (GOS) |
| Matching PlaceboAlso: Sugar powder10-15 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. | Other | Placebo |
Primary outcome
Mean Composite PROMIS Maximum Scores
Time frame: Between week 0 (Baseline) and week 4
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 item score within that domain (range 0-4). Using the seven domain severity scores, a composite PROMIS maximum GI measure was calculated for each visit. Composite PROMIS maximum was defined as the maximum severity score cumulatively across all seven domains, representing the participant's worst GI symptoms at that time point. The range of the composite PROMIS maximum score is 0-28 with lower scores representing lowest GI symptoms.
12 secondary outcomes
Mean Percent Change in Relative Abundance of Beneficial Bacteria
Time frame: Between week 0 (Baseline) and week 4
Interleukin-1α Concentration
Time frame: Between week 0 (Baseline) and week 4
Interleukin-1ß Concentration
Time frame: Between week 0 (Baseline) and week 4
Interleukin-6 Concentration
Time frame: Between week 0 (Baseline) and week 4
Interleukin-8 Concentration
Time frame: Between week 0 (Baseline) and week 4
Interleukin-12 Concentration
Time frame: Between week 0 (Baseline) and week 4
Interleukin-17 Concentration
Time frame: Between week 0 (Baseline) and week 4
Interleukin-18 Concentration
Time frame: Between week 0 (Baseline) and week 4
Tumor Necrosis Factor Alpha (TNF-α) Concentration
Time frame: Between week 0 (Baseline) and week 4
Interferon Gamma (IFNγ) Concentration
Time frame: Between week 0 (Baseline) and week 4
Change in C-Reactive Protein Concentration
Time frame: Between week 0 (Baseline) and week 4
Change in Zonulin Concentration
Time frame: Between week 0 (Baseline) and week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvia Becker-Dreps, MD, MPH principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Humanized" galacto-oligosaccharides (hGOS) and Galacto-oligosaccharides (GOS) in people with Intestinal Health, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Composite PROMIS Maximum Scores (time frame: Between week 0 (Baseline) and week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.